October 15, 2025 • 53 mins
Welcome to All Things Biosimilar Podcast
Join Andrew Bourgoin, founder of Bourgoin Insights Group, as he introduces the All Things Biosimilar Podcast, an insightful series dedicated to the US biosimilars market. With over 15 years of industry experience, Andrew discusses various topics related to the market. Subscribe now to stay informed about the evolving U.S. biosimilars landscape.
In Episode Two of the All Things Biosimilar Podcast:
Biosimilars and Total Addressable Market Analysis, U.S. Retina Market Dynamics, Q3 Earnings Season Preview
00:00 Introduction and Episode Overview
01:47 Feedback from Episode One
02:36 Topic 1: Understanding TAM in Biosimilars
05:51 Case Study: Coherus and TAM Analysis
07:21 Detailed Market Analysis: Remicade, Herceptin, and Lucentis
18:08 Portfolio Analysis and Future Projections
24:04 Applying TAM Scenarios to Companies
28:03 Analyzing Biosimilar Market Performance
29:31 Exploring the US Retina Market
30:54 Competitive Landscape for Aflibercept Biosimilars
35:51 Upcoming Biosimilar Market Activities
40:09 Earnings Season Preview: Key Questions and Topics
43:15 Company-Specific Earnings Insights
52:55 Conclusion and Upcoming Episodes
Connect with us!
Website:
www.Bourgoininsightsgroup.com
LinkedIn:
https://www.linkedin.com/company/bourgoin-insights-group
Music:
Bang Boom - Captain Joz
Production:
Maine Frame
Disclaimer:
Bourgoin Insights Group, LLC publishes market intelligence reports on various Biosimilars, Biologics, and the U.S. Biosimilar industry. All reports, both published publicly and those provided pursuant to part of a subscription to All Things Biosimilar are subject to the following disclaimer. A subscription to All Things Biosimilar automatically indicates acceptance of the disclaimer.
We, at Bourgoin Insights Group, LLC, gather information from various sources such paid databases, published reports, FDA databases, annual reports, surveys and media releases. This public information is collated in good faith in preparation of analysis and used on an as is and as available basis by us.
Mark as Played
Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Andrew Bourgoin (00:06):
Welcome to the All Things Biosimilar podcast.
On today's episode, we havethree more big topics to
discuss.
The first biosimilars and TAM,or total addressable market.
This is a metric that is oftenused to help identify what the
future potential could be for abiosimilars product or
portfolio.
(00:26):
We do an analysis to try tounderstand how informative that.
Really could be.
Number two, the retina market.
Lots going on in the USbiosimilars, retina market, and
even beyond biosimilars.
We'll go through the latestoverview of the Eylea
competitive set, as well as whatare some of the key act
activities, topics, actions thatare happening over the course of
(00:49):
the next 12 months.
Finally, it's earning season.
Q3 earnings are startingtomorrow, so we're going to give
a handful of questions andconsiderations that are top of
mind for us for some of thebranded biosimilar companies
that will be reporting.
I'm Andrew Burgo.
This is the All ThingsBiosimilar podcast.
(01:11):
Let's get started.
(01:44):
Welcome.
Here we go, episode two.
You mean to say that episode onewent well enough that we're
doing another one?
Yes, indeed we are.
In fact, I got some positivefeedback from that good old
first episode in September.
Folks said.
Loved it.
Great to get your thoughts onthese topics.
(02:05):
It was helpful to listen to it,even watch it.
And so here we are, episodenumber two.
The biggest piece of feedbackthat I'll be implementing today
is to go on a little bit longer.
Episode one was only 12minutes-ish.
This week's is a bit longer aswe're covering some topics that
actually require a bit moreanalysis and, that means a
(02:27):
little bit more of me.
So thank you for listening intoday.
Excited to get started on ourfirst big topic.
Let's go.
Okay.
So big topic number one,biosimilars and TAM.
Or total addressable market.
(02:49):
This is a metric that many ofyou are likely familiar with.
TAM is also often used with Samand som, which we're gonna put
to the side today.
But why it's important inbiosimilars?
It's often used, especially bypublic companies or companies
looking for investment toidentify what the future
potential opportunity could befor biosimilars.
And really it's not that hard tofigure out.
(03:14):
When it comes to biosimilars,and why is that?
If you know what products are inyour portfolio, then you know
the reference products by whichthe marketplace you're going to
be competing in.
So TAM is relatively easy tofigure out.
Companies usually just look atthe future peak sales of the
(03:35):
reference product.
And there's your TAM.
Now, of course there's somenuances that can be put on that
figure to maybe help refine it abit, get a little bit sharpened
up.
Maybe you're trying to thinkabout whether or not biosimilars
could grow that number by havingmore affordable versions of it
(03:57):
on the market.
Maybe it's not going to be asattractive of a market than
those peak sales.
Because of headwinds from apolicy perspective or innovative
products shrinking the marketsize, but in general, loss of
exclusivity minus one peaksales.
(04:18):
For the most part is the numberthat would be used to underpin a
TAM analysis.
Now, again, while it'srelatively easy to figure out
what that number is, what's muchmore challenging is to figure
out actually what will be thenet revenue or net sales of a
(04:41):
biosimilar based on that number.
Let's take Humira for example.
In the US in 2022, Humira's netsales was about$18 billion,
right?
$18 billion would be the TAM.
Now, how does that numberhelping to inform how any of the
(05:04):
biosimilar Adalimumab productsare performing in the market
today?
It's challenging.
Big time.
Especially because we see someproducts doing relatively well
and others not doing as well.
So with that numerator being thesame across all biosimilar
products, that ultimateperformance there's variation
(05:25):
there, and that's what we wantto talk about today is what's
that connection between TAM andactual biosimilar performance?
Then how could we apply that tosome of the TAM figures that
biosimilar companies are talkingabout with regards to the value
of their portfolio?
(05:46):
Before we jump into theanalysis.
Just an example, right?
Not too long ago, many of youare familiar with Coherus.
This is a company that focusedsolely on biosimilars for many
years, had multiple biosimilarsin their portfolio.
Humira, Neulasta, had an Avastinand Eylea for some time, of
(06:07):
course, had a Lucentis productas well.
Now, you can see here from apresentation that they did in
2017.
The number 40 billion is used asa pipeline opportunity.
No, 40 billion.
That would be potentially theTAM of that portfolio.
Whereas in reality, when we lookat the revenue for Coherus
(06:32):
products from 21 to 24.
It was about a billion dollars.
And this is not a judgment orany type of position on how
successful that portfolio or theexecution of it was in the US
market, by no means, in fact,coherence and how well they did
with some of these products seenas a success.
(06:54):
What we're focusing on is thatrelationship between how well
those products did in the$40billion.
Number that was used as theopportunity, and that's what
we'll be talking about today.
The difference between.
What's being talked about as thefuture potential and maybe some
of the realities that presentthemselves.
(07:14):
How can we bridge that gap tothink about where we're going
here for some of the biosimilarcompanies?
Here's the breakdown of theanalysis that we did.
We took three markets, Remicade,Herceptin, and Lucentis, and we
selected two biosimilars fromeach one of those markets to
review publicly publicly knownrevenue.
(07:35):
It really what drove us toselect these or threefold,
number one, it's a good mix ofsome.
Of the different TAs that we seein biosimilar competition,
immunology, oncology, andretina.
And also each one of those,brand brands itself, we were
able to use the publiclyreported information to see what
(07:57):
their peak net sales were beforebiosimilar competition entered.
The second or the third thinghere that was really helpful is
that.
For each one of the productsthat we use in the analysis from
a biosimilar perspective,Inflectra Xi for the Infliximab
space, KTI and Reon for theHerceptin or Trastuzumab space.
And then similarly in bio Iszwhen it came to the Rani market,
(08:21):
those are all publicly reportedas well, right?
With some caveats for similarly,after the acquisition by Sandos,
it was really helpful for us touse that information instead of
trying to source and trulyunderstand, either IQ via or
Symphony or some sort of datathere.
This is all publicly reportedinformation.
And so that's really what helpedus shape the set that we
(08:44):
included in this analysis.
And so what we did was we lookedat the peak.
Net sales that was reported forInfliximab Remicade, Herceptin
and Lucentis.
Because of course those peaksales would reflect what the TAM
was, right?
And then we looked at theperformance of the biosimilars
(09:06):
from launch until 2024.
And we identified what anaverage annual revenue was from
each one of those pro products.
And we put together then, a casefor each of the products that
said, okay, here's the averagerevenue and here's the TAM.
What's the percentage of thatTAM that each one of these
(09:27):
biosimilars contributed from arevenue perspective annually?
That's step one.
Step two, we then made aportfolio, the good old big US
biosimilars portfolio.
I selected seven products, Ibelieve that are losing
exclusivity or planning toexperience biosimilar
competition between now and.
2033 and we identified what thepeak sales in the US would be
(09:52):
for each of those products.
And we applied different casesor different experiences from
each of the biosimilars listedhere to products in that
portfolio.
If we did three differentscenarios, some performing
better than others, and we getto another number that helps us
understand from a portfolioperspective with the variance
(10:15):
that occurs for each biosimilarwithin a portfolio what is the
percentage of TAM that portfoliocaptured?
The last step is then we take.
Those three scenarios and theoutputs from them, and we apply
them to some of the companiesthat talk about TAM, just to get
a better sense of what thefuture, again, potential
(10:37):
opportunity could be.
Going from that massive numberdown to potentially reality.
That's the analysis that we'regonna walk you through here.
Let's go ahead and get startedwith the three different
markets.
So we start first with theInfliximab market or Remicade,
(10:59):
right?
This is one of the first marketsthat experienced biosimilar
competition here in the us andas you can see the reported net
sales for Remicade in the US wasabout 4.8 billion back in 2016.
That's the year that Inflectraentered the marketplace as well.
And Inflectra, their peak US netsales were about 385.
(11:21):
Million dollars.
That's one case that we'll lookat.
Xis, as you can see, slightlydifferent, launched a little bit
later, but with peak net salesthus far 234 million.
Now, each of these products hada different story in the
marketplace.
Inflectra first to launch.
(11:43):
As you can see, it took a bitfor it to ramp up from a market
share perspective, but when itdid.
It gained a leadershipperspective, actually captured a
good percentage of the marketand retains around 30%.
We made a archetype here formarket share capture for
Infector around 25%, first tolaunch 25% market share.
(12:05):
And run Flex is a slightlydifferent story, second to
launch in the marketplace, butas you can see it.
It started to get off theground, but then never truly
did.
More competitors entered thespace.
And we created an archetype forReflexis around 7.5% of market
share capture.
Now, pulling all these piecestogether, okay, the analysis
(12:28):
here you can see for Inflectra.
Really what we're trying to getto is that one number that looks
at what's the average revenue ornet sales for the product, the
biosimilar over its o over itstime in market.
And what percentage of the brandpeak sales does that represent?
(12:49):
So the brand peak sales, that'sthe TAM, and then the average US
net sales of the biosimilar forInflectra, we see that was about
5%.
All right, so re flexis slightlylower at around 3%.
Alright.
Same TAM, same peak net sales ofLucentis, I'm sorry, of
(13:11):
Remicade, but amount that wascaptured on average.
For reflexes slightly lower thanInflectra.
Now we did the same thing againin the Herceptin or Trastuzumab
market.
And you can see here forHerceptin, the peak sales just
under 3 billion, so lower thanRemicade.
(13:34):
But then when we look at theCanti and ent, Trant Peak sales.
KTI actually was almost at halfa billion dollars here, 479
million in peak sales, whereasAndreza, about a 10th of that at
around 48 million.
So very different experiencesfor these two products.
(13:57):
And when you look at the buildover time, you can see Canty
first to market captured.
Boy, they were up to about 40.
42% ish.
There for about a year, morecompetitors came to the
marketplace.
We created an archetype there of30%.
Overall they're around 31%.
(14:17):
As of this report that we usefrom Samsung whereas Treant
different story.
Entre on later entrant.
And overall around 2.5% marketshare.
Which resulted in, in ouranalysis, kti on average was
capturing about 10% annually inrevenue of what the peak sales
(14:43):
of us Herceptin, right?
Entre on the other, sa on theother hand, was about 1%.
So again, same TAM.
Herceptin in the United States,two very different stories, and
what percentage of that TAM wascaptured on an annual basis on
average by Canti and Entru.
(15:06):
On the last example here isLucentis or Ranibizumab.
Now.
You can see here, even lowerthan Herceptin.
Lucentis peak sales were about1.8 billion in 2017.
The biosimilars launched quite abit after that.
So some of the decline in theRanibizumab market is likely a
(15:27):
reflection of.
Eylea and Vabysmo gaining quitea bit of market share, but still
similarly in bio Viz inthemselves had very different
experiences.
Peak sales for similarly, atleast in 23, we believe probably
in 24 it did a little bit morethan this, but we don't have
that data.
From Sandoz.
They don't report specificallyon product performance, but 1 25
(15:51):
for similarly, whereas Bio Vizpeak sales in 24 is around 37
million.
Now, this is always aninteresting anecdote to share.
You know the difference betweensimilarly and bios similarly was
actually second to market andwas able to capture much more
share than bios.
We use an archetype here of 35%,even though we can see there
(16:12):
were moments where over 50%market share were similarly.
Whereas bio instead, we capturedmuch lower around 5%.
A couple times it peaked upthere a little bit.
But overall you can see when westart to bring this to the
analysis that very differentnumbers for similarly in Bio viz
on average.
(16:33):
Similarly annual sales, actuallywe're about 3% of the Lucentis
US TAM Bio Viz, on the otherhand, was less than 1%.
Alright, so this tells the storyyet again, that despite having
the same total opportunity ofthe marketplace, different
(16:54):
biosimilars are going tocapture, different market share
and ultimately drive differentlevels of contribution in their
revenue.
Now we capture all of that hereagain in the o overview of the
TAM analysis that we did.
So starting from left to righthere, we see kti at around 10,
(17:16):
just under 10% of the annual.
Net sales or revenue of K Jdiwas about 10% of the peak sales
of Herceptin.
Okay.
Inflectra, closer to 5%, right?
Still.
Very strong product.
Been on the market for a verylong time and and run flexis
(17:37):
then is actually closer to 3%and as we go further.
Down the line here from left toyou can see going from KTI all
the way down to Bio V.
We see, KTI at about 10% of TAM,where bio vis is about a 10th of
a percent of TAM biggesttakeaway, right?
(17:58):
Each one of these cases is avery different way by which a
biosimilar could actuallycapture some of that TAM.
So what we do now is we takeeach one of these cases and we
apply it to the very excitingbig portfolio of biosimilar
(18:19):
products.
Now let me introduce you to thisportfolio.
So this is seven products thatwe identified as products that
are going to experiencebiosimilar competition between
now and 2033.
You can see here this includesOpdivo, Keytruda, Ocrevus,
Darzalex, Taya, Dupixent, andEylea hd.
(18:43):
Now each of these products.
Is indeed a a target formultiple biosimilar companies.
We've listed some of the oneshere.
Obviously Keytruda is on a lotof people's radars.
But also Opdivo and Ocrevus.
Are targeted by both Amgen andSandoz.
Sandoz, in fact is has publiclyannounced that they're working
(19:06):
on biosimilar versions of all ofthese products.
We, we collected the US peakestimated net sales based on
Wall Street estimates and putthem in here.
And you can see that for theseseven products, we would say the
TAM, at least for the US market,the TAM is about$72 billion for
(19:29):
this portfolio.
Now we take this and like Isaid, start applying different
scenarios that use those casesto start to get an idea of what
that.
Total 72 billion could actuallymean for my makeshift, pretend
(19:50):
by a similar company that hasthis portfolio.
Let's go through the firstscenario that we've titled one
Canti, which actually means thatwe applied the Canti case that
10%.
Capture of the TAM.
We applied that KTI case to oneof the products in our
(20:13):
portfolio.
In this first scenario, there isa winner, right?
There is one product that isperforming quite well across the
biosimilar class.
That's the Canti case in, in, inthis first scenario that's
applied to Ocrevus.
And as you can see here again.
Ocrevus estimated peak saleshere in the US is about 6.6
(20:37):
billion, and K de capturingabout 10% of that throughout the
rest of the portfolio.
In this first scenario, we'vealso included and applied the
Reon Rexi, similarly, Inflectraand bio viz cases.
(20:57):
Across the different productswithin the portfolio.
All in together this portfolioannual average, using these
cases and having, again, thatone product that is doing quite
well.
The KTI case is about$2 billionfor this portfolio, which.
(21:18):
Reflects 2.8% of that$72 billionTAM.
Okay, so this first scenario isfilled with a lot of different
types of performing biosimilars,some less than 1% capture, and
then of course, at least onethat is highly successful in its
(21:42):
biosimilar competitive set.
Scenario two takes that oneCanty case off the table.
There is no biosimilar that'sperforming as well.
As the ti case in scenario two,here we say there's one
Inflectra.
And in Fletcher's case for thisscenario was applied to Opdivo.
(22:05):
Again, Inflectra is about wesaid 5% annual revenue as a
percentage of the TAM.
And so here you can see againInflectra capturing that amount,
and we applied Enton Bio Vizsimilarly in Xis cases to the
rest of the portfolio.
(22:26):
All in this scenario shows about1.3 actually closer to$1.4
billion.
An annual revenue, which is 1.9%of that$72 billion TAM.
The third scenario is not anuncommon scenario.
This is one where there are no.
(22:51):
Canis or Inflectra.
In fact, there's a lot of entruand bio vis cases that were
applied.
Again, these are products thatmaybe are capturing 1%, if not
below 1% of that totaladdressable market number on an
annual basis.
(23:11):
So when you look here that thescenario three portfolio
actually captures about half abillion, which represents 0.7%
of that$72 billion TAM.
So take away from this step ofthe analysis is to understand
that 72 billion TAM.
(23:36):
Can be realized in verydifferent ways depending on the
performance of each of thebiosimilars within that
competitive set.
And here we've created a rangeusing some application of the
different cases that we'vecreated across the portfolios.
(23:58):
Now let's kinda ladder up to whywe're doing this to begin with.
There's a lot of TAM or totaladdressable market talk in the
marketplace.
So we did a review of, publiclyreported information.
We have four examples here.
Alva Tech, Fresenius, Sandoz,and Teva, all in their earnings
(24:21):
calls or in, in, in companypresentations.
Talk about TAM.
And what we did here is we justlooked at.
Assets from 2025 and beyond, andwhat that number was based on
what they have shared.
And you can see here both Sandozand Altech have a pretty high
number.
Sandoz here are$200 billion fortheir global TAM.
(24:45):
And then, smaller number ofproducts, smaller TAM for
Fresenius, and then again withTeva.
Now this last phase of theanalysis takes these numbers and
applies the three scenarios thatwe created.
So the first step in doing this,we needed to try to convert from
(25:09):
that global TAM to just a USnumber.
And we chose 70%.
We did this because we looked ata handful of reference products.
And for the most part, amajority of sales occurs in the
US marketplace.
This is an assumption.
All this analysis isdirectional.
70% here scopes just for the TAMof the region.
(25:32):
And you can see that gets us toabout, one 30 for Alva Tech,
about 80 for Fresenius, one 40for Sandoz and Teva with a TAM
of the US market owned 57billion now.
We apply the different scenariosto then think what could be the
annual contribution from thatbiosimilars portfolio going from
(25:57):
the massive TAM down to what andif.
These companies pr potentiallyhave a canty like performance
from one of their biosimilars.
You can see the numbers here areactually quite attractive.
Now, we did add a 50% riskadjustment.
(26:18):
Okay, so the 2.8% that was aresult of scenario one's
analysis is down to 1.4 becauseas many of not all biosimilars
get regulatory approval.
The products that do getregulatory approval don't always
launch.
Some of them.
(26:38):
Get approved in 2018 and thencan't launch until 2028.
We did create a risk adjustmenthere.
Some folks might think it's tooaggressive.
Other folks might think it it'sclose to reasonable regardless.
Even with that risk adjustment,we can see, Sandoz here is
knocking on the door of 2billion and they're taking just
(26:59):
over 1%.
Of that TAM.
And this, again, this is us, USmarket, right?
When we look at scenario two,now again, maybe no canty
driving.
Revenue but instead a, anothersolid archetype here for
(27:20):
Inflectra.
And what you see here is stillthe companies with pretty large
portfolios and TAM are stillover a billion dollars right
now.
When you get to scenario three,these numbers decline.
And this is where if theportfolio is not, does not have
a lot of products that arereally leading in their class,
(27:43):
capturing a lot of share.
You're seeing the numbers,closer to half a billion or
below.
Alright.
Big takeaway here again.
TAM, massive number.
How informative is that actuallyhow the portfolios, companies,
and products will do well?
Like everything in biosimilars,it depends.
(28:06):
Here our analysis shows thateven in a scenario where you
have one product that performsas well as one of the best
biosimilars to launch in the USto date, you're still going to
be, potentially at around 1%,one point half percent of what
that TAM could be because.
(28:27):
The rest of your portfolioprobably won't be filled with
those numbers or products thatare performing as well as a
canty cases.
And then the more products thatyou have that are weighted for
that low performance side, themore challenging it is.
Some obvious takeaways here, butactually putting numbers to it
(28:49):
we find is always helpful.
Now, we will be evolving thisanalysis because it's everything
that's happening in betweenthere that influences whether or
not your TAM is closer to ascenario one or a scenario
three.
And what are some of those keythings that help you have,
(29:09):
success in a market versus not?
More to come there and almosteven more importantly, is what
happens after that revenue?
How do you turn that revenueinto profitability?
What is the opex or sg and ainvestment that has to occur to
achieve some of these numbers tobegin with?
More to come there too.
(29:31):
But for now, we're just gonna goahead and start on the second
big topic of today, which is thewild US retina market.
All right, so the US retinamarket, super interesting space.
Biosimilars have been competingin this market already.
(29:53):
We just talked through some ofthe Lucentis biosimilars.
Similarly in bio vis.
They've been on the market since20 21, 20 22, and PAB Blue, of
course, this is a product fromAmgen, is the first biosimilar
version of Eylea to come to themarket.
This launched almost a year agotoday.
So retina is familiar withbiosimilars.
(30:15):
We've seen biosimilars besuccessful in this space, and
we're going to see a lot moreactivity over the course of the
next 12 months with regards toretina.
Biosimilars and some of the keychanges in the marketplace that
certainly will create morecompetition and we will be
(30:36):
monitoring.
We wanted to go through whatsome of those key activities
are, some of those events,occurrences that were
anticipating, and also do areasonable level set on the
Eylea biosimilar market who thecompetitors are and some of the
latest updates that we've seen.
So this is our all thingsbiosimilar competitive landscape
(30:59):
for the US market, forAflibercept.
As we mentioned, Amgen's alreadycompeting in this space.
They launched at the end ofOctober last year.
And the product is done quitewell.
We're seeing that potentiallythis might be between a four and
$500 million product in itsfirst year on the marketplace.
(31:19):
And importantly in its label, ithas both the vial and the
prefilled syringe.
Both of these are in the Eyleatwo milligram label.
And as we'll see, prefilledsyringe is something that
certainly might create a littlevariance in the marketplace.
PLU does not haveinterchangeability nor does
Amgen have another Ranibizumabor another retina product in
(31:43):
this case of Ranibizumabbiosimilar in its portfolio.
Alright, we will come back towhether or not either of those
things are important as we gothrough the list.
You can see here the dark bluesquares on the left.
These are all products that havebeen approved yet none of them
are yet to be on themarketplace.
Celltrion just got approved thispast week.
(32:06):
And some of these products havebeen approved now for far over a
year.
We'll start with APU Viz.
This is a product that hasdeveloped, manufactured by
Samsung Bios.
And this was a product that.
Was a part of the Biogenrelationship in the US
commercial rights, along withBio Viz Harrop Pharmaceuticals
(32:27):
will be launching this productin 2026.
And as you can see while thecurrent label doesn't have
prefilled syringe in it.
We would anticipate that itmight by launch.
It's an approved product.
It has interchangeability, andas we know, they have
Ranibizumab biosimilar also intheir portfolio.
If we go down and look atSandoz, we see again another
(32:52):
company with a Ranibizumab inits portfolio.
What will be interesting is tounderstand how, these
Ranibizumab products similarlyin bio viz are used within the
marketplace.
We know Sandoz has pausedcommercialization of similarly
at this time and they plan toreintroduce it either at the end
(33:13):
of this year, beginning of nextyear based on some of the recent
statements from leadership.
But Sandoz also has two otherthings going for it right now,
as of now.
That hero's product does not.
And the first is the prefilledsyringe and label.
Again, we anticipate probablyall these products will have
prefilled syringe in its labelat some point.
(33:35):
But Sandoz's product does thesecond thing that Sandoz has
right now that.
That APU vis is without isclarity on market launch.
Sandos announced not too longago that they'll have a, they
have a settlement in place withRegeneron and they'll be able to
bring their product to market inQ4 26.
(33:57):
Now, Foran also announced thatthis will be the case for them.
They'll be launching, or they'llhave the opportunity to launch
the product at the end of 26 aswell.
But they'll be doing it throughtheir partner Valorem Biologics.
We are tracking activity withvalorem through their
partnership actually with XBrain for a Ranibizumab product.
(34:20):
You can see here, there that'son a review.
And we anticipate actually PDUFAor BAS UFA date for that
product.
Next week.
Biocon is also participating inthis market.
And they actually were the firstcompany to settle with Regeneron
the reference product sponsor.
And they have a market entrydate of second half, 20, 26.
(34:42):
Now, we don't know details aboutany of these dates.
These are you.
Three to six month timeframeshere by which they've been
communicating to, to the public.
But we would anticipate thatbiocom would be second to market
under these existing conditions.
Now again, Reon also hasapproval here.
(35:04):
They got prefilled syringe intheir label.
But there's uncertainty aroundtheir launch timing as well as
hero's launch timing.
Now, Teva and their partner,Alva Tech have a.
PDUA date or SFA date coming uphere very soon.
And we can see that with Tevaand even potentially Fresenius
(35:24):
Kabi.
That's creating quite acompetitive marketplace.
We already know that there aresix approved products with one
competing in the market.
Add two more, that's eight allin.
For a product Eylea twomilligram.
That is also going to get somemarket pressure from both Eylea
(35:49):
HD and Vabysmo.
And in thinking about why thatis and what's happening over the
next 12 months, like we said,we're expecting a lot of things
to occur in this market thatwe're monitoring.
The first happening next week isthis.
Is this A-P-D-F-A date for theproposed biosimilar version of
Ranibizumab from X Brain?
(36:11):
And if this product getsapproved, this would be the
third biosimilar version ofRanibizumab here in the us.
And this would be the firstproduct that Valorem Biologics
has at least biosimilar.
We remain curious as to theplace Ranibizumab has with
biosimilar Aflibercept not onlyavailable, but with many more to
(36:35):
become available.
And we will be watching closelynext week for this announcement.
And also, watching closely withregards to Eylea HD prefilled
syringe.
Without going into too muchdetail in the history of this
there's been continuingchallenges with the Catalent
plant in Indiana.
This is the plant that themanufacturing plant that the BLA
(36:58):
was filed with actually.
Even today, Regeneron announcedthat there'll be in the next
three months filing to have a,another plant included in the
BLA which doesn't bode well fora a launch or an approval of the
Eylea HD prefilled syringe inthe immediate to near term.
(37:19):
We, the company, Regeneron, hasshared that, the update on the
prefilled syringe and the PDUFAwould be coming in late October.
We look to that as a keycatalyst here in this
marketplace because with thatprefilled syringe, Eylea HD
actually might see increaseutilization and put pressure on
the Eylea two milligram market.
(37:41):
Of which PBL is actually doingquite well, and we will be
celebrating its first birthdayhere on October 31st.
I have shared that I think thatthis potentially could be one of
the most successful, if not themost successful first year
biosimilar launch for any USbiosimilar to date.
And we will see how that stacksup here likely in the next
(38:03):
podcast.
Along with that prefilledsyringe, PDU pdufa for Eylea hd,
there's also an RVO, anotherindication that's on the two
milligram label.
It's yet to be included on theeight milligram or the Eylea HD
label.
But once there is inclusion,again, more patients potentially
that are on two milligram, whereHD is, a better option for them
(38:27):
those RVO patients, ones onlabel potentially could go
there.
And then, we turn to 26 andthat's where.
A lot of biosimilar activitycould potentially be happening
in this space.
As we mentioned, similarly hasbeen paused commercially and
there's anticipation for thatproduct to be relaunched either
(38:48):
at the end of this year orbeginning of next year.
Now, how similarly comes tomarket?
How will it be used?
Will it be used in a way to, tosupport Sandoz's Eylea
biosimilar.
Is there a place for Ranibizumabbiosimilar anymore with Pav Blue
competing?
That's a question that certainlywe'll be watching both for
(39:09):
similarly relaunch and heroes.
Launch of Bio Viz, which theysaid at their investor day is
gonna be mid 2026, so we seemaybe the first half of next
year as potential reintroductionof some of the Ranibizumab
biosimilars.
What does that look like?
Does it matter?
And how will it matter if itdoes where then the second half
(39:31):
of next year becomes all aboutthis next phase or wave of
Aflibercept biosimilars withBiogen's product, Sandoz's
product form Econs product orvalorem biologics.
Product competing in themarketplace and potentially
others as well.
So a lot going on over thecourse of the next 12 months is
(39:55):
this is a space that we findfascinating and certainly
something that we'll befollowing.
And hopefully this update hasbeen helpful.
All right, onto the final bigtopic of the episode, and this
is all about earnings, right?
(40:17):
Starting tomorrow actually areall things biosimilar coverage
of of earnings begins withJohnson and Johnson.
And as you can see here, there'sa handful of companies that we
go ahead, either listen to thecall or read the transcript,
oftentimes both and put togetherour reflections on biosimilar
(40:39):
related topics from thesecompanies.
What we wanted to do in thisepisode is share with you ahead
of earning season what some ofthe interesting questions or
topics or considerations.
Related to the US biosimilarsmarket that we're going to be
listening for.
And this is both on the brandside as well as the biosimilars
(41:00):
side.
So we've selected a fewcompanies to start with.
The first is tomorrow's callwith Johnson and Johnson.
There's three things that we'refocused on here, but primarily
how's it going with Stelara?
J and j has taken a positionsimilar to how AbbVie did.
(41:20):
Where they believe that, theHumira erosion and impact was an
archetype by which Stelara wasgoing to follow the same path.
And part of that isn't just thedegree of erosion, but where the
utilization or the scripts andpatients go during during that
time for AbbVie.
(41:42):
That was a lot of patients andutilization wasn't just going
from Humira to biosimilarversions of Humira, but some of
it was going from hi Humira tosome of the new MOAs.
So the Skyrizi and the Vos.
JJ was thinking probably wouldbe something similar, right?
Where all Stelara utilizationthat would migrate, wouldn't
(42:06):
just be to the Stelarabiosimilars.
In fact, maybe some of it wouldgo to Tremfya.
And that's where, we really wantto see number one, stelara's
erosion since really,biosimilars started getting
uptake with coverage at thebeginning of Q2.
And w.
Trajectory wise, is it alongwhat JJ and J was anticipating?
(42:29):
Number two, is that TFI line isthat also in line with what they
were anticipating with regardsto capturing some of that
business from Stelara versusbiosimilars capturing that
business?
And overall we're just curiouson the immunology market basket
for Johnson and what theperformance is.
(42:49):
We know Remicade continues to doquite well.
It's annualizing it around abillion dollars a year for that
company.
How is that going?
And then number two reallytrying to understand Simponi and
Simponi Aria.
That's a product that of coursewe're anticipating biosimilar
competition.
And as that product nears, LOEhow well is it performing?
(43:13):
So that's j and j tomorrow.
A week from now, plus a fewdays.
Thursday, October 23rd SamsungBiologics is reporting.
Now.
This is an interesting one forus because, there's a spin
happening, right?
Biologics and bios are becomingtwo separate entities.
And we're really interested tolearn more about this.
(43:36):
The timeline for which they wereplanning to spin.
It was supposed to be earlyOctober, now it's pushed to
early, no November.
So any updates on that it willbe exciting for us also.
We're curious if as EPIsHoldings company, the new entity
becomes established will therebe.
New information about thepipeline, right?
(43:57):
We know that a lot of companiesin the biosimilars market over
the course of 2025, specificallySandoz and Alva Tech, have
released more names of.
The products that they'redeveloping.
We know that Samsung has yet toreally expand their list of
biosimilars that they're workingon in the past few quarters.
(44:20):
And it would be reallyinteresting to know what
additional assets they'redeveloping with the launch of
EPIs Holdings Company.
That might be an interestingtime to to do that.
So we're excited to see more.
From biologics.
Roche obviously a very importantcompany when it comes to
biosimilars because.
(44:40):
Like Amgen a lot of thereference products come from,
Roche's incredible r and d.
There's a few specifically thatwe're interested in this
quarter.
The first is Actemra.
Actemra has now threebiosimilars competing in the US
market.
Nne, toin, and ama.
(45:02):
Over the course of the pastyear, Actemra has actually
performed, I think, aboveexpectations and has really
retained a good.
Portion of the Tocilizumabshare.
And estimates are suggestingthat in Q3 this could start to
decline.
We're curious to see the rate bywhich it does, if it does as
(45:23):
that may reflect that some ofthe biosimilars are actually
starting to become a bit morecompetitive.
Second is Xolair.
So like Simponi we expect Xolairto be a biosimilars market that
opens sometime in 2026.
What's really interesting aboutXolair is that this is an older
(45:44):
product.
It's been around, but it hassome indications that have,
really just turned on over thepast five, six years, or Decaria
is one of them, but also foodallergy and food allergy we've
seen is growing in this market.
You can see here between Q1 andQ2, there's a 35% growth in
Xolair quarter over quarter likethat is pretty impressive.
(46:07):
Q3 estimates showing thiscalming down quite a bit.
But.
We're going to be curious againto see how that product,
especially in that segment,continues to grow.
Because if you think about it,for a lot of biologics, a lot of
these reference products thathave biosimilar competition,
they're competing in a marketfor decades before biosimilars
(46:29):
enter.
Humira, Remicade Enbrel, theseare products that have been
around for.
Decades.
I think Enbrels 1998, right?
Like they've been around, theseare known entities.
These have, they have builtindustry and I.
With that comes a degree ofequity trust.
(46:52):
And that's something that whenbiosimilars launch after 15, 20
years from the original launchof the reference product, it's
sometimes it's very hard tobreak into.
So layer in food allergy reallyhasn't been competing for that
long.
So if biosimilars are launchingand they're able to compete in
that segment.
Maybe some of that brand equityisn't as strong, and this is one
(47:16):
of the reasons why we continueto monitor this space.
The last product within theRoche portfolio that we're going
to be monitoring here isVabysmo.
We just talked about all theactivity happening in retina,
and primarily we're focusing onAflibercept, right?
The Eylea, hd and all thebiosimilars and how they're
competing.
Vabysmo is a product that'scontinuing to do quite well in
(47:39):
this space.
We have a business questionthat's open around does all of
this change and complication inthe Aflibercept world?
Create some sort of fatigue.
Is there, oh, I can't rememberwhich biosimilars being covered.
How many do I have to have in myfridge?
I don't, what's going on withthis one I can't even pronounce.
(48:01):
Oh vabysmo.
That's clean.
We don't have to worry aboutanything.
We know the product.
There aren't 10 biosimilars wehave to worry about.
Is there going to be any type ofuplift for vabysmo because of
the new complexities and thecompetitive set for the
Aflibercept market?
That's something that we'llcontinue to look at.
Here are the 12% estimatedgrowth quarter over quarter.
(48:24):
Here for VA advisement.
We'll see on Thursday, October23rd if that reads through.
Regeneron of course.
Really don't wanna talk too muchabout this one'cause it's
obvious here.
We wanna see how the twomilligrams doing and how HD's
doing.
The positioning here has beenthat HD continues to grow and
Eylea is doing just fine.
(48:46):
How much is IH is HD going togrow, especially if there's
continued delays on theprefilled syringe side.
And overall, what is the size ofthe Eylea franchise?
Is that trending down here?
Estimates are showingpotentially that's going to drop
a little bit here in the us.
But of course all lies on Eyleahd prefilled syringe and what
(49:08):
happens there?
Of course Sandos, Sandos is oneof the companies in biosimilars.
Questionably has the deepestbench of portfolio products.
We remain focused on, of course,US market here and how their
current business is doing.
Sandoz, unlike some of the otherbiosimilar companies they don't
(49:31):
report out specifically onproducts, nor do they report
specifically on the us.
It's part of the North Americasegment here.
And when we look at theirbiosimilars revenue as a
function of the North Americasegment it's actually.
The second smallest segmentacross any that they report on,
right?
Either generics or biosimilarsacross Europe, international or
(49:54):
North America.
Now.
We don't know how much of thateight 15 is the US market.
We also aren't entirely sureexactly where they capture some
of the business from from theprivate label deals.
So our question and what we'reinterested to continue to hear
about with Sandoz is just howwell the US is doing.
(50:15):
Right?
PI GVAs launched, they've gotante and EOS now in the
marketplace.
Huma.
Might be the most successfuladalimumab biosimilar competing
in the US market.
All of these together how wellis the US business doing?
That's what we're excited tohear.
Any hopefully any informationaround how well the non-private
(50:39):
label business is doing is alsoinformative to us.
And we're looking forward tothat.
Last company here that we'regonna highlight today is Amgen.
Amgen's, one of the fun ones tolisten to because they talk
about their branded portfolioand implications of biosimilar
competition and then of coursetheir biosimilars themselves.
So for us, obviously, X-G-E-V-Aand Prolia this is the first
(51:02):
earnings call where there'sactually gonna be a handful of
months of competition frombiosimilars, predominantly from
ante and W ost.
And how well, is the defensestrategy going now, remember,
Prolia is is a very high volumemarket.
There's a lot of Prolia.
Units out there.
(51:22):
And so if there is impact, weprobably will see it.
This chart here pulled from theterminal is showing us that
there are, are declinesdirectionally happening for both
those products.
We would expect that's a degreeof which it's happening, that
the ramp or the D ramp in thiscase, that's important.
The second thing is divinity.
If that is pushing up.
(51:45):
Interesting to hear how the teamtalks about that.
And of course we're also curiousjust to hear Pab blue's numbers
as well as was Lana.
We may get numbers on was Lana.
We may not, we're not reallysure exactly how that's
captured, so we're exci excitedto hear a bit more of that.
With regards to Amgen's earningsas well.
(52:07):
Plenty of other companies thatwe follow.
And we are excited to learneverything from is AbbVie going
to give another haircut toHumira revenue estimates to, is
Pfizer going to share more aboutTrump Rx and Aubrey Lattas
inclusion in that?
(52:27):
So over the course of the nextfive, six weeks.
A lot a lot to learn, a lot forus to get excited about here.
And all this, of course, isincluded to our premium
subscribers who get our earningsreview coverage.
We put out our notes.
Within 24 hours after the afterthe earnings calls and also some
(52:49):
tidbits of each of those, wepull into the 3 51 K report,
which is part of our basicsubscription service.
If there was any other questions that you
might have beyond what was intoday's show be it about the all
things biosimilar subscriptionor Burg Insights Group in
general, by all means, pleasereach out.
But thank you so much forlistening today.
(53:11):
And look for the next episode,hopefully to come just in time
for Thanksgiving.
And then one more before the endof the year.
Wishing you all a wonderfulOctober and talk to you soon.
Thanks.
Welcome to the All Things Biosimilar podcast.
On today's episode, we havethree more big topics to
discuss.
The first biosimilars and TAM,or total addressable market.
This is a metric that is oftenused to help identify what the
future potential could be for abiosimilars product or
portfolio.
(00:26):
We do an analysis to try tounderstand how informative that.
Really could be.
Number two, the retina market.
Lots going on in the USbiosimilars, retina market, and
even beyond biosimilars.
We'll go through the latestoverview of the Eylea
competitive set, as well as whatare some of the key act
activities, topics, actions thatare happening over the course of
(00:49):
the next 12 months.
Finally, it's earning season.
Q3 earnings are startingtomorrow, so we're going to give
a handful of questions andconsiderations that are top of
mind for us for some of thebranded biosimilar companies
that will be reporting.
I'm Andrew Burgo.
This is the All ThingsBiosimilar podcast.
(01:11):
Let's get started.
(01:44):
Welcome.
Here we go, episode two.
You mean to say that episode onewent well enough that we're
doing another one?
Yes, indeed we are.
In fact, I got some positivefeedback from that good old
first episode in September.
Folks said.
Loved it.
Great to get your thoughts onthese topics.
(02:05):
It was helpful to listen to it,even watch it.
And so here we are, episodenumber two.
The biggest piece of feedbackthat I'll be implementing today
is to go on a little bit longer.
Episode one was only 12minutes-ish.
This week's is a bit longer aswe're covering some topics that
actually require a bit moreanalysis and, that means a
(02:27):
little bit more of me.
So thank you for listening intoday.
Excited to get started on ourfirst big topic.
Let's go.
Okay.
So big topic number one,biosimilars and TAM.
Or total addressable market.
(02:49):
This is a metric that many ofyou are likely familiar with.
TAM is also often used with Samand som, which we're gonna put
to the side today.
But why it's important inbiosimilars?
It's often used, especially bypublic companies or companies
looking for investment toidentify what the future
potential opportunity could befor biosimilars.
And really it's not that hard tofigure out.
(03:14):
When it comes to biosimilars,and why is that?
If you know what products are inyour portfolio, then you know
the reference products by whichthe marketplace you're going to
be competing in.
So TAM is relatively easy tofigure out.
Companies usually just look atthe future peak sales of the
(03:35):
reference product.
And there's your TAM.
Now, of course there's somenuances that can be put on that
figure to maybe help refine it abit, get a little bit sharpened
up.
Maybe you're trying to thinkabout whether or not biosimilars
could grow that number by havingmore affordable versions of it
(03:57):
on the market.
Maybe it's not going to be asattractive of a market than
those peak sales.
Because of headwinds from apolicy perspective or innovative
products shrinking the marketsize, but in general, loss of
exclusivity minus one peaksales.
(04:18):
For the most part is the numberthat would be used to underpin a
TAM analysis.
Now, again, while it'srelatively easy to figure out
what that number is, what's muchmore challenging is to figure
out actually what will be thenet revenue or net sales of a
(04:41):
biosimilar based on that number.
Let's take Humira for example.
In the US in 2022, Humira's netsales was about$18 billion,
right?
$18 billion would be the TAM.
Now, how does that numberhelping to inform how any of the
(05:04):
biosimilar Adalimumab productsare performing in the market
today?
It's challenging.
Big time.
Especially because we see someproducts doing relatively well
and others not doing as well.
So with that numerator being thesame across all biosimilar
products, that ultimateperformance there's variation
(05:25):
there, and that's what we wantto talk about today is what's
that connection between TAM andactual biosimilar performance?
Then how could we apply that tosome of the TAM figures that
biosimilar companies are talkingabout with regards to the value
of their portfolio?
(05:46):
Before we jump into theanalysis.
Just an example, right?
Not too long ago, many of youare familiar with Coherus.
This is a company that focusedsolely on biosimilars for many
years, had multiple biosimilarsin their portfolio.
Humira, Neulasta, had an Avastinand Eylea for some time, of
(06:07):
course, had a Lucentis productas well.
Now, you can see here from apresentation that they did in
2017.
The number 40 billion is used asa pipeline opportunity.
No, 40 billion.
That would be potentially theTAM of that portfolio.
Whereas in reality, when we lookat the revenue for Coherus
(06:32):
products from 21 to 24.
It was about a billion dollars.
And this is not a judgment orany type of position on how
successful that portfolio or theexecution of it was in the US
market, by no means, in fact,coherence and how well they did
with some of these products seenas a success.
(06:54):
What we're focusing on is thatrelationship between how well
those products did in the$40billion.
Number that was used as theopportunity, and that's what
we'll be talking about today.
The difference between.
What's being talked about as thefuture potential and maybe some
of the realities that presentthemselves.
(07:14):
How can we bridge that gap tothink about where we're going
here for some of the biosimilarcompanies?
Here's the breakdown of theanalysis that we did.
We took three markets, Remicade,Herceptin, and Lucentis, and we
selected two biosimilars fromeach one of those markets to
review publicly publicly knownrevenue.
(07:35):
It really what drove us toselect these or threefold,
number one, it's a good mix ofsome.
Of the different TAs that we seein biosimilar competition,
immunology, oncology, andretina.
And also each one of those,brand brands itself, we were
able to use the publiclyreported information to see what
(07:57):
their peak net sales were beforebiosimilar competition entered.
The second or the third thinghere that was really helpful is
that.
For each one of the productsthat we use in the analysis from
a biosimilar perspective,Inflectra Xi for the Infliximab
space, KTI and Reon for theHerceptin or Trastuzumab space.
And then similarly in bio Iszwhen it came to the Rani market,
(08:21):
those are all publicly reportedas well, right?
With some caveats for similarly,after the acquisition by Sandos,
it was really helpful for us touse that information instead of
trying to source and trulyunderstand, either IQ via or
Symphony or some sort of datathere.
This is all publicly reportedinformation.
And so that's really what helpedus shape the set that we
(08:44):
included in this analysis.
And so what we did was we lookedat the peak.
Net sales that was reported forInfliximab Remicade, Herceptin
and Lucentis.
Because of course those peaksales would reflect what the TAM
was, right?
And then we looked at theperformance of the biosimilars
(09:06):
from launch until 2024.
And we identified what anaverage annual revenue was from
each one of those pro products.
And we put together then, a casefor each of the products that
said, okay, here's the averagerevenue and here's the TAM.
What's the percentage of thatTAM that each one of these
(09:27):
biosimilars contributed from arevenue perspective annually?
That's step one.
Step two, we then made aportfolio, the good old big US
biosimilars portfolio.
I selected seven products, Ibelieve that are losing
exclusivity or planning toexperience biosimilar
competition between now and.
2033 and we identified what thepeak sales in the US would be
(09:52):
for each of those products.
And we applied different casesor different experiences from
each of the biosimilars listedhere to products in that
portfolio.
If we did three differentscenarios, some performing
better than others, and we getto another number that helps us
understand from a portfolioperspective with the variance
(10:15):
that occurs for each biosimilarwithin a portfolio what is the
percentage of TAM that portfoliocaptured?
The last step is then we take.
Those three scenarios and theoutputs from them, and we apply
them to some of the companiesthat talk about TAM, just to get
a better sense of what thefuture, again, potential
(10:37):
opportunity could be.
Going from that massive numberdown to potentially reality.
That's the analysis that we'regonna walk you through here.
Let's go ahead and get startedwith the three different
markets.
So we start first with theInfliximab market or Remicade,
(10:59):
right?
This is one of the first marketsthat experienced biosimilar
competition here in the us andas you can see the reported net
sales for Remicade in the US wasabout 4.8 billion back in 2016.
That's the year that Inflectraentered the marketplace as well.
And Inflectra, their peak US netsales were about 385.
(11:21):
Million dollars.
That's one case that we'll lookat.
Xis, as you can see, slightlydifferent, launched a little bit
later, but with peak net salesthus far 234 million.
Now, each of these products hada different story in the
marketplace.
Inflectra first to launch.
(11:43):
As you can see, it took a bitfor it to ramp up from a market
share perspective, but when itdid.
It gained a leadershipperspective, actually captured a
good percentage of the marketand retains around 30%.
We made a archetype here formarket share capture for
Infector around 25%, first tolaunch 25% market share.
(12:05):
And run Flex is a slightlydifferent story, second to
launch in the marketplace, butas you can see it.
It started to get off theground, but then never truly
did.
More competitors entered thespace.
And we created an archetype forReflexis around 7.5% of market
share capture.
Now, pulling all these piecestogether, okay, the analysis
(12:28):
here you can see for Inflectra.
Really what we're trying to getto is that one number that looks
at what's the average revenue ornet sales for the product, the
biosimilar over its o over itstime in market.
And what percentage of the brandpeak sales does that represent?
(12:49):
So the brand peak sales, that'sthe TAM, and then the average US
net sales of the biosimilar forInflectra, we see that was about
5%.
All right, so re flexis slightlylower at around 3%.
Alright.
Same TAM, same peak net sales ofLucentis, I'm sorry, of
(13:11):
Remicade, but amount that wascaptured on average.
For reflexes slightly lower thanInflectra.
Now we did the same thing againin the Herceptin or Trastuzumab
market.
And you can see here forHerceptin, the peak sales just
under 3 billion, so lower thanRemicade.
(13:34):
But then when we look at theCanti and ent, Trant Peak sales.
KTI actually was almost at halfa billion dollars here, 479
million in peak sales, whereasAndreza, about a 10th of that at
around 48 million.
So very different experiencesfor these two products.
(13:57):
And when you look at the buildover time, you can see Canty
first to market captured.
Boy, they were up to about 40.
42% ish.
There for about a year, morecompetitors came to the
marketplace.
We created an archetype there of30%.
Overall they're around 31%.
(14:17):
As of this report that we usefrom Samsung whereas Treant
different story.
Entre on later entrant.
And overall around 2.5% marketshare.
Which resulted in, in ouranalysis, kti on average was
capturing about 10% annually inrevenue of what the peak sales
(14:43):
of us Herceptin, right?
Entre on the other, sa on theother hand, was about 1%.
So again, same TAM.
Herceptin in the United States,two very different stories, and
what percentage of that TAM wascaptured on an annual basis on
average by Canti and Entru.
(15:06):
On the last example here isLucentis or Ranibizumab.
Now.
You can see here, even lowerthan Herceptin.
Lucentis peak sales were about1.8 billion in 2017.
The biosimilars launched quite abit after that.
So some of the decline in theRanibizumab market is likely a
(15:27):
reflection of.
Eylea and Vabysmo gaining quitea bit of market share, but still
similarly in bio Viz inthemselves had very different
experiences.
Peak sales for similarly, atleast in 23, we believe probably
in 24 it did a little bit morethan this, but we don't have
that data.
From Sandoz.
They don't report specificallyon product performance, but 1 25
(15:51):
for similarly, whereas Bio Vizpeak sales in 24 is around 37
million.
Now, this is always aninteresting anecdote to share.
You know the difference betweensimilarly and bios similarly was
actually second to market andwas able to capture much more
share than bios.
We use an archetype here of 35%,even though we can see there
(16:12):
were moments where over 50%market share were similarly.
Whereas bio instead, we capturedmuch lower around 5%.
A couple times it peaked upthere a little bit.
But overall you can see when westart to bring this to the
analysis that very differentnumbers for similarly in Bio viz
on average.
(16:33):
Similarly annual sales, actuallywe're about 3% of the Lucentis
US TAM Bio Viz, on the otherhand, was less than 1%.
Alright, so this tells the storyyet again, that despite having
the same total opportunity ofthe marketplace, different
(16:54):
biosimilars are going tocapture, different market share
and ultimately drive differentlevels of contribution in their
revenue.
Now we capture all of that hereagain in the o overview of the
TAM analysis that we did.
So starting from left to righthere, we see kti at around 10,
(17:16):
just under 10% of the annual.
Net sales or revenue of K Jdiwas about 10% of the peak sales
of Herceptin.
Okay.
Inflectra, closer to 5%, right?
Still.
Very strong product.
Been on the market for a verylong time and and run flexis
(17:37):
then is actually closer to 3%and as we go further.
Down the line here from left toyou can see going from KTI all
the way down to Bio V.
We see, KTI at about 10% of TAM,where bio vis is about a 10th of
a percent of TAM biggesttakeaway, right?
(17:58):
Each one of these cases is avery different way by which a
biosimilar could actuallycapture some of that TAM.
So what we do now is we takeeach one of these cases and we
apply it to the very excitingbig portfolio of biosimilar
(18:19):
products.
Now let me introduce you to thisportfolio.
So this is seven products thatwe identified as products that
are going to experiencebiosimilar competition between
now and 2033.
You can see here this includesOpdivo, Keytruda, Ocrevus,
Darzalex, Taya, Dupixent, andEylea hd.
(18:43):
Now each of these products.
Is indeed a a target formultiple biosimilar companies.
We've listed some of the oneshere.
Obviously Keytruda is on a lotof people's radars.
But also Opdivo and Ocrevus.
Are targeted by both Amgen andSandoz.
Sandoz, in fact is has publiclyannounced that they're working
(19:06):
on biosimilar versions of all ofthese products.
We, we collected the US peakestimated net sales based on
Wall Street estimates and putthem in here.
And you can see that for theseseven products, we would say the
TAM, at least for the US market,the TAM is about$72 billion for
(19:29):
this portfolio.
Now we take this and like Isaid, start applying different
scenarios that use those casesto start to get an idea of what
that.
Total 72 billion could actuallymean for my makeshift, pretend
(19:50):
by a similar company that hasthis portfolio.
Let's go through the firstscenario that we've titled one
Canti, which actually means thatwe applied the Canti case that
10%.
Capture of the TAM.
We applied that KTI case to oneof the products in our
(20:13):
portfolio.
In this first scenario, there isa winner, right?
There is one product that isperforming quite well across the
biosimilar class.
That's the Canti case in, in, inthis first scenario that's
applied to Ocrevus.
And as you can see here again.
Ocrevus estimated peak saleshere in the US is about 6.6
(20:37):
billion, and K de capturingabout 10% of that throughout the
rest of the portfolio.
In this first scenario, we'vealso included and applied the
Reon Rexi, similarly, Inflectraand bio viz cases.
(20:57):
Across the different productswithin the portfolio.
All in together this portfolioannual average, using these
cases and having, again, thatone product that is doing quite
well.
The KTI case is about$2 billionfor this portfolio, which.
(21:18):
Reflects 2.8% of that$72 billionTAM.
Okay, so this first scenario isfilled with a lot of different
types of performing biosimilars,some less than 1% capture, and
then of course, at least onethat is highly successful in its
(21:42):
biosimilar competitive set.
Scenario two takes that oneCanty case off the table.
There is no biosimilar that'sperforming as well.
As the ti case in scenario two,here we say there's one
Inflectra.
And in Fletcher's case for thisscenario was applied to Opdivo.
(22:05):
Again, Inflectra is about wesaid 5% annual revenue as a
percentage of the TAM.
And so here you can see againInflectra capturing that amount,
and we applied Enton Bio Vizsimilarly in Xis cases to the
rest of the portfolio.
(22:26):
All in this scenario shows about1.3 actually closer to$1.4
billion.
An annual revenue, which is 1.9%of that$72 billion TAM.
The third scenario is not anuncommon scenario.
This is one where there are no.
(22:51):
Canis or Inflectra.
In fact, there's a lot of entruand bio vis cases that were
applied.
Again, these are products thatmaybe are capturing 1%, if not
below 1% of that totaladdressable market number on an
annual basis.
(23:11):
So when you look here that thescenario three portfolio
actually captures about half abillion, which represents 0.7%
of that$72 billion TAM.
So take away from this step ofthe analysis is to understand
that 72 billion TAM.
(23:36):
Can be realized in verydifferent ways depending on the
performance of each of thebiosimilars within that
competitive set.
And here we've created a rangeusing some application of the
different cases that we'vecreated across the portfolios.
(23:58):
Now let's kinda ladder up to whywe're doing this to begin with.
There's a lot of TAM or totaladdressable market talk in the
marketplace.
So we did a review of, publiclyreported information.
We have four examples here.
Alva Tech, Fresenius, Sandoz,and Teva, all in their earnings
(24:21):
calls or in, in, in companypresentations.
Talk about TAM.
And what we did here is we justlooked at.
Assets from 2025 and beyond, andwhat that number was based on
what they have shared.
And you can see here both Sandozand Altech have a pretty high
number.
Sandoz here are$200 billion fortheir global TAM.
(24:45):
And then, smaller number ofproducts, smaller TAM for
Fresenius, and then again withTeva.
Now this last phase of theanalysis takes these numbers and
applies the three scenarios thatwe created.
So the first step in doing this,we needed to try to convert from
(25:09):
that global TAM to just a USnumber.
And we chose 70%.
We did this because we looked ata handful of reference products.
And for the most part, amajority of sales occurs in the
US marketplace.
This is an assumption.
All this analysis isdirectional.
70% here scopes just for the TAMof the region.
(25:32):
And you can see that gets us toabout, one 30 for Alva Tech,
about 80 for Fresenius, one 40for Sandoz and Teva with a TAM
of the US market owned 57billion now.
We apply the different scenariosto then think what could be the
annual contribution from thatbiosimilars portfolio going from
(25:57):
the massive TAM down to what andif.
These companies pr potentiallyhave a canty like performance
from one of their biosimilars.
You can see the numbers here areactually quite attractive.
Now, we did add a 50% riskadjustment.
(26:18):
Okay, so the 2.8% that was aresult of scenario one's
analysis is down to 1.4 becauseas many of not all biosimilars
get regulatory approval.
The products that do getregulatory approval don't always
launch.
Some of them.
(26:38):
Get approved in 2018 and thencan't launch until 2028.
We did create a risk adjustmenthere.
Some folks might think it's tooaggressive.
Other folks might think it it'sclose to reasonable regardless.
Even with that risk adjustment,we can see, Sandoz here is
knocking on the door of 2billion and they're taking just
(26:59):
over 1%.
Of that TAM.
And this, again, this is us, USmarket, right?
When we look at scenario two,now again, maybe no canty
driving.
Revenue but instead a, anothersolid archetype here for
(27:20):
Inflectra.
And what you see here is stillthe companies with pretty large
portfolios and TAM are stillover a billion dollars right
now.
When you get to scenario three,these numbers decline.
And this is where if theportfolio is not, does not have
a lot of products that arereally leading in their class,
(27:43):
capturing a lot of share.
You're seeing the numbers,closer to half a billion or
below.
Alright.
Big takeaway here again.
TAM, massive number.
How informative is that actuallyhow the portfolios, companies,
and products will do well?
Like everything in biosimilars,it depends.
(28:06):
Here our analysis shows thateven in a scenario where you
have one product that performsas well as one of the best
biosimilars to launch in the USto date, you're still going to
be, potentially at around 1%,one point half percent of what
that TAM could be because.
(28:27):
The rest of your portfolioprobably won't be filled with
those numbers or products thatare performing as well as a
canty cases.
And then the more products thatyou have that are weighted for
that low performance side, themore challenging it is.
Some obvious takeaways here, butactually putting numbers to it
(28:49):
we find is always helpful.
Now, we will be evolving thisanalysis because it's everything
that's happening in betweenthere that influences whether or
not your TAM is closer to ascenario one or a scenario
three.
And what are some of those keythings that help you have,
(29:09):
success in a market versus not?
More to come there and almosteven more importantly, is what
happens after that revenue?
How do you turn that revenueinto profitability?
What is the opex or sg and ainvestment that has to occur to
achieve some of these numbers tobegin with?
More to come there too.
(29:31):
But for now, we're just gonna goahead and start on the second
big topic of today, which is thewild US retina market.
All right, so the US retinamarket, super interesting space.
Biosimilars have been competingin this market already.
(29:53):
We just talked through some ofthe Lucentis biosimilars.
Similarly in bio vis.
They've been on the market since20 21, 20 22, and PAB Blue, of
course, this is a product fromAmgen, is the first biosimilar
version of Eylea to come to themarket.
This launched almost a year agotoday.
So retina is familiar withbiosimilars.
(30:15):
We've seen biosimilars besuccessful in this space, and
we're going to see a lot moreactivity over the course of the
next 12 months with regards toretina.
Biosimilars and some of the keychanges in the marketplace that
certainly will create morecompetition and we will be
(30:36):
monitoring.
We wanted to go through whatsome of those key activities
are, some of those events,occurrences that were
anticipating, and also do areasonable level set on the
Eylea biosimilar market who thecompetitors are and some of the
latest updates that we've seen.
So this is our all thingsbiosimilar competitive landscape
(30:59):
for the US market, forAflibercept.
As we mentioned, Amgen's alreadycompeting in this space.
They launched at the end ofOctober last year.
And the product is done quitewell.
We're seeing that potentiallythis might be between a four and
$500 million product in itsfirst year on the marketplace.
(31:19):
And importantly in its label, ithas both the vial and the
prefilled syringe.
Both of these are in the Eyleatwo milligram label.
And as we'll see, prefilledsyringe is something that
certainly might create a littlevariance in the marketplace.
PLU does not haveinterchangeability nor does
Amgen have another Ranibizumabor another retina product in
(31:43):
this case of Ranibizumabbiosimilar in its portfolio.
Alright, we will come back towhether or not either of those
things are important as we gothrough the list.
You can see here the dark bluesquares on the left.
These are all products that havebeen approved yet none of them
are yet to be on themarketplace.
Celltrion just got approved thispast week.
(32:06):
And some of these products havebeen approved now for far over a
year.
We'll start with APU Viz.
This is a product that hasdeveloped, manufactured by
Samsung Bios.
And this was a product that.
Was a part of the Biogenrelationship in the US
commercial rights, along withBio Viz Harrop Pharmaceuticals
(32:27):
will be launching this productin 2026.
And as you can see while thecurrent label doesn't have
prefilled syringe in it.
We would anticipate that itmight by launch.
It's an approved product.
It has interchangeability, andas we know, they have
Ranibizumab biosimilar also intheir portfolio.
If we go down and look atSandoz, we see again another
(32:52):
company with a Ranibizumab inits portfolio.
What will be interesting is tounderstand how, these
Ranibizumab products similarlyin bio viz are used within the
marketplace.
We know Sandoz has pausedcommercialization of similarly
at this time and they plan toreintroduce it either at the end
(33:13):
of this year, beginning of nextyear based on some of the recent
statements from leadership.
But Sandoz also has two otherthings going for it right now,
as of now.
That hero's product does not.
And the first is the prefilledsyringe and label.
Again, we anticipate probablyall these products will have
prefilled syringe in its labelat some point.
(33:35):
But Sandoz's product does thesecond thing that Sandoz has
right now that.
That APU vis is without isclarity on market launch.
Sandos announced not too longago that they'll have a, they
have a settlement in place withRegeneron and they'll be able to
bring their product to market inQ4 26.
(33:57):
Now, Foran also announced thatthis will be the case for them.
They'll be launching, or they'llhave the opportunity to launch
the product at the end of 26 aswell.
But they'll be doing it throughtheir partner Valorem Biologics.
We are tracking activity withvalorem through their
partnership actually with XBrain for a Ranibizumab product.
(34:20):
You can see here, there that'son a review.
And we anticipate actually PDUFAor BAS UFA date for that
product.
Next week.
Biocon is also participating inthis market.
And they actually were the firstcompany to settle with Regeneron
the reference product sponsor.
And they have a market entrydate of second half, 20, 26.
(34:42):
Now, we don't know details aboutany of these dates.
These are you.
Three to six month timeframeshere by which they've been
communicating to, to the public.
But we would anticipate thatbiocom would be second to market
under these existing conditions.
Now again, Reon also hasapproval here.
(35:04):
They got prefilled syringe intheir label.
But there's uncertainty aroundtheir launch timing as well as
hero's launch timing.
Now, Teva and their partner,Alva Tech have a.
PDUA date or SFA date coming uphere very soon.
And we can see that with Tevaand even potentially Fresenius
(35:24):
Kabi.
That's creating quite acompetitive marketplace.
We already know that there aresix approved products with one
competing in the market.
Add two more, that's eight allin.
For a product Eylea twomilligram.
That is also going to get somemarket pressure from both Eylea
(35:49):
HD and Vabysmo.
And in thinking about why thatis and what's happening over the
next 12 months, like we said,we're expecting a lot of things
to occur in this market thatwe're monitoring.
The first happening next week isthis.
Is this A-P-D-F-A date for theproposed biosimilar version of
Ranibizumab from X Brain?
(36:11):
And if this product getsapproved, this would be the
third biosimilar version ofRanibizumab here in the us.
And this would be the firstproduct that Valorem Biologics
has at least biosimilar.
We remain curious as to theplace Ranibizumab has with
biosimilar Aflibercept not onlyavailable, but with many more to
(36:35):
become available.
And we will be watching closelynext week for this announcement.
And also, watching closely withregards to Eylea HD prefilled
syringe.
Without going into too muchdetail in the history of this
there's been continuingchallenges with the Catalent
plant in Indiana.
This is the plant that themanufacturing plant that the BLA
(36:58):
was filed with actually.
Even today, Regeneron announcedthat there'll be in the next
three months filing to have a,another plant included in the
BLA which doesn't bode well fora a launch or an approval of the
Eylea HD prefilled syringe inthe immediate to near term.
(37:19):
We, the company, Regeneron, hasshared that, the update on the
prefilled syringe and the PDUFAwould be coming in late October.
We look to that as a keycatalyst here in this
marketplace because with thatprefilled syringe, Eylea HD
actually might see increaseutilization and put pressure on
the Eylea two milligram market.
(37:41):
Of which PBL is actually doingquite well, and we will be
celebrating its first birthdayhere on October 31st.
I have shared that I think thatthis potentially could be one of
the most successful, if not themost successful first year
biosimilar launch for any USbiosimilar to date.
And we will see how that stacksup here likely in the next
(38:03):
podcast.
Along with that prefilledsyringe, PDU pdufa for Eylea hd,
there's also an RVO, anotherindication that's on the two
milligram label.
It's yet to be included on theeight milligram or the Eylea HD
label.
But once there is inclusion,again, more patients potentially
that are on two milligram, whereHD is, a better option for them
(38:27):
those RVO patients, ones onlabel potentially could go
there.
And then, we turn to 26 andthat's where.
A lot of biosimilar activitycould potentially be happening
in this space.
As we mentioned, similarly hasbeen paused commercially and
there's anticipation for thatproduct to be relaunched either
(38:48):
at the end of this year orbeginning of next year.
Now, how similarly comes tomarket?
How will it be used?
Will it be used in a way to, tosupport Sandoz's Eylea
biosimilar.
Is there a place for Ranibizumabbiosimilar anymore with Pav Blue
competing?
That's a question that certainlywe'll be watching both for
(39:09):
similarly relaunch and heroes.
Launch of Bio Viz, which theysaid at their investor day is
gonna be mid 2026, so we seemaybe the first half of next
year as potential reintroductionof some of the Ranibizumab
biosimilars.
What does that look like?
Does it matter?
And how will it matter if itdoes where then the second half
(39:31):
of next year becomes all aboutthis next phase or wave of
Aflibercept biosimilars withBiogen's product, Sandoz's
product form Econs product orvalorem biologics.
Product competing in themarketplace and potentially
others as well.
So a lot going on over thecourse of the next 12 months is
(39:55):
this is a space that we findfascinating and certainly
something that we'll befollowing.
And hopefully this update hasbeen helpful.
All right, onto the final bigtopic of the episode, and this
is all about earnings, right?
(40:17):
Starting tomorrow actually areall things biosimilar coverage
of of earnings begins withJohnson and Johnson.
And as you can see here, there'sa handful of companies that we
go ahead, either listen to thecall or read the transcript,
oftentimes both and put togetherour reflections on biosimilar
(40:39):
related topics from thesecompanies.
What we wanted to do in thisepisode is share with you ahead
of earning season what some ofthe interesting questions or
topics or considerations.
Related to the US biosimilarsmarket that we're going to be
listening for.
And this is both on the brandside as well as the biosimilars
(41:00):
side.
So we've selected a fewcompanies to start with.
The first is tomorrow's callwith Johnson and Johnson.
There's three things that we'refocused on here, but primarily
how's it going with Stelara?
J and j has taken a positionsimilar to how AbbVie did.
(41:20):
Where they believe that, theHumira erosion and impact was an
archetype by which Stelara wasgoing to follow the same path.
And part of that isn't just thedegree of erosion, but where the
utilization or the scripts andpatients go during during that
time for AbbVie.
(41:42):
That was a lot of patients andutilization wasn't just going
from Humira to biosimilarversions of Humira, but some of
it was going from hi Humira tosome of the new MOAs.
So the Skyrizi and the Vos.
JJ was thinking probably wouldbe something similar, right?
Where all Stelara utilizationthat would migrate, wouldn't
(42:06):
just be to the Stelarabiosimilars.
In fact, maybe some of it wouldgo to Tremfya.
And that's where, we really wantto see number one, stelara's
erosion since really,biosimilars started getting
uptake with coverage at thebeginning of Q2.
And w.
Trajectory wise, is it alongwhat JJ and J was anticipating?
(42:29):
Number two, is that TFI line isthat also in line with what they
were anticipating with regardsto capturing some of that
business from Stelara versusbiosimilars capturing that
business?
And overall we're just curiouson the immunology market basket
for Johnson and what theperformance is.
(42:49):
We know Remicade continues to doquite well.
It's annualizing it around abillion dollars a year for that
company.
How is that going?
And then number two reallytrying to understand Simponi and
Simponi Aria.
That's a product that of coursewe're anticipating biosimilar
competition.
And as that product nears, LOEhow well is it performing?
(43:13):
So that's j and j tomorrow.
A week from now, plus a fewdays.
Thursday, October 23rd SamsungBiologics is reporting.
Now.
This is an interesting one forus because, there's a spin
happening, right?
Biologics and bios are becomingtwo separate entities.
And we're really interested tolearn more about this.
(43:36):
The timeline for which they wereplanning to spin.
It was supposed to be earlyOctober, now it's pushed to
early, no November.
So any updates on that it willbe exciting for us also.
We're curious if as EPIsHoldings company, the new entity
becomes established will therebe.
New information about thepipeline, right?
(43:57):
We know that a lot of companiesin the biosimilars market over
the course of 2025, specificallySandoz and Alva Tech, have
released more names of.
The products that they'redeveloping.
We know that Samsung has yet toreally expand their list of
biosimilars that they're workingon in the past few quarters.
(44:20):
And it would be reallyinteresting to know what
additional assets they'redeveloping with the launch of
EPIs Holdings Company.
That might be an interestingtime to to do that.
So we're excited to see more.
From biologics.
Roche obviously a very importantcompany when it comes to
biosimilars because.
(44:40):
Like Amgen a lot of thereference products come from,
Roche's incredible r and d.
There's a few specifically thatwe're interested in this
quarter.
The first is Actemra.
Actemra has now threebiosimilars competing in the US
market.
Nne, toin, and ama.
(45:02):
Over the course of the pastyear, Actemra has actually
performed, I think, aboveexpectations and has really
retained a good.
Portion of the Tocilizumabshare.
And estimates are suggestingthat in Q3 this could start to
decline.
We're curious to see the rate bywhich it does, if it does as
(45:23):
that may reflect that some ofthe biosimilars are actually
starting to become a bit morecompetitive.
Second is Xolair.
So like Simponi we expect Xolairto be a biosimilars market that
opens sometime in 2026.
What's really interesting aboutXolair is that this is an older
(45:44):
product.
It's been around, but it hassome indications that have,
really just turned on over thepast five, six years, or Decaria
is one of them, but also foodallergy and food allergy we've
seen is growing in this market.
You can see here between Q1 andQ2, there's a 35% growth in
Xolair quarter over quarter likethat is pretty impressive.
(46:07):
Q3 estimates showing thiscalming down quite a bit.
But.
We're going to be curious againto see how that product,
especially in that segment,continues to grow.
Because if you think about it,for a lot of biologics, a lot of
these reference products thathave biosimilar competition,
they're competing in a marketfor decades before biosimilars
(46:29):
enter.
Humira, Remicade Enbrel, theseare products that have been
around for.
Decades.
I think Enbrels 1998, right?
Like they've been around, theseare known entities.
These have, they have builtindustry and I.
With that comes a degree ofequity trust.
(46:52):
And that's something that whenbiosimilars launch after 15, 20
years from the original launchof the reference product, it's
sometimes it's very hard tobreak into.
So layer in food allergy reallyhasn't been competing for that
long.
So if biosimilars are launchingand they're able to compete in
that segment.
Maybe some of that brand equityisn't as strong, and this is one
(47:16):
of the reasons why we continueto monitor this space.
The last product within theRoche portfolio that we're going
to be monitoring here isVabysmo.
We just talked about all theactivity happening in retina,
and primarily we're focusing onAflibercept, right?
The Eylea, hd and all thebiosimilars and how they're
competing.
Vabysmo is a product that'scontinuing to do quite well in
(47:39):
this space.
We have a business questionthat's open around does all of
this change and complication inthe Aflibercept world?
Create some sort of fatigue.
Is there, oh, I can't rememberwhich biosimilars being covered.
How many do I have to have in myfridge?
I don't, what's going on withthis one I can't even pronounce.
(48:01):
Oh vabysmo.
That's clean.
We don't have to worry aboutanything.
We know the product.
There aren't 10 biosimilars wehave to worry about.
Is there going to be any type ofuplift for vabysmo because of
the new complexities and thecompetitive set for the
Aflibercept market?
That's something that we'llcontinue to look at.
Here are the 12% estimatedgrowth quarter over quarter.
(48:24):
Here for VA advisement.
We'll see on Thursday, October23rd if that reads through.
Regeneron of course.
Really don't wanna talk too muchabout this one'cause it's
obvious here.
We wanna see how the twomilligrams doing and how HD's
doing.
The positioning here has beenthat HD continues to grow and
Eylea is doing just fine.
(48:46):
How much is IH is HD going togrow, especially if there's
continued delays on theprefilled syringe side.
And overall, what is the size ofthe Eylea franchise?
Is that trending down here?
Estimates are showingpotentially that's going to drop
a little bit here in the us.
But of course all lies on Eyleahd prefilled syringe and what
(49:08):
happens there?
Of course Sandos, Sandos is oneof the companies in biosimilars.
Questionably has the deepestbench of portfolio products.
We remain focused on, of course,US market here and how their
current business is doing.
Sandoz, unlike some of the otherbiosimilar companies they don't
(49:31):
report out specifically onproducts, nor do they report
specifically on the us.
It's part of the North Americasegment here.
And when we look at theirbiosimilars revenue as a
function of the North Americasegment it's actually.
The second smallest segmentacross any that they report on,
right?
Either generics or biosimilarsacross Europe, international or
(49:54):
North America.
Now.
We don't know how much of thateight 15 is the US market.
We also aren't entirely sureexactly where they capture some
of the business from from theprivate label deals.
So our question and what we'reinterested to continue to hear
about with Sandoz is just howwell the US is doing.
(50:15):
Right?
PI GVAs launched, they've gotante and EOS now in the
marketplace.
Huma.
Might be the most successfuladalimumab biosimilar competing
in the US market.
All of these together how wellis the US business doing?
That's what we're excited tohear.
Any hopefully any informationaround how well the non-private
(50:39):
label business is doing is alsoinformative to us.
And we're looking forward tothat.
Last company here that we'regonna highlight today is Amgen.
Amgen's, one of the fun ones tolisten to because they talk
about their branded portfolioand implications of biosimilar
competition and then of coursetheir biosimilars themselves.
So for us, obviously, X-G-E-V-Aand Prolia this is the first
(51:02):
earnings call where there'sactually gonna be a handful of
months of competition frombiosimilars, predominantly from
ante and W ost.
And how well, is the defensestrategy going now, remember,
Prolia is is a very high volumemarket.
There's a lot of Prolia.
Units out there.
(51:22):
And so if there is impact, weprobably will see it.
This chart here pulled from theterminal is showing us that
there are, are declinesdirectionally happening for both
those products.
We would expect that's a degreeof which it's happening, that
the ramp or the D ramp in thiscase, that's important.
The second thing is divinity.
If that is pushing up.
(51:45):
Interesting to hear how the teamtalks about that.
And of course we're also curiousjust to hear Pab blue's numbers
as well as was Lana.
We may get numbers on was Lana.
We may not, we're not reallysure exactly how that's
captured, so we're exci excitedto hear a bit more of that.
With regards to Amgen's earningsas well.
(52:07):
Plenty of other companies thatwe follow.
And we are excited to learneverything from is AbbVie going
to give another haircut toHumira revenue estimates to, is
Pfizer going to share more aboutTrump Rx and Aubrey Lattas
inclusion in that?
(52:27):
So over the course of the nextfive, six weeks.
A lot a lot to learn, a lot forus to get excited about here.
And all this, of course, isincluded to our premium
subscribers who get our earningsreview coverage.
We put out our notes.
Within 24 hours after the afterthe earnings calls and also some
(52:49):
tidbits of each of those, wepull into the 3 51 K report,
which is part of our basicsubscription service.
If there was any other questions that you
might have beyond what was intoday's show be it about the all
things biosimilar subscriptionor Burg Insights Group in
general, by all means, pleasereach out.
But thank you so much forlistening today.
(53:11):
And look for the next episode,hopefully to come just in time
for Thanksgiving.
And then one more before the endof the year.
Wishing you all a wonderfulOctober and talk to you soon.
Thanks.
Popular Podcasts
Las Culturistas with Matt Rogers and Bowen Yang
Ding dong! Join your culture consultants, Matt Rogers and Bowen Yang, on an unforgettable journey into the beating heart of CULTURE. Alongside sizzling special guests, they GET INTO the hottest pop-culture moments of the day and the formative cultural experiences that turned them into Culturistas. Produced by the Big Money Players Network and iHeartRadio.
The Joe Rogan Experience
The official podcast of comedian Joe Rogan.
Stuff You Should Know
If you've ever wanted to know about champagne, satanism, the Stonewall Uprising, chaos theory, LSD, El Nino, true crime and Rosa Parks, then look no further. Josh and Chuck have you covered.