October 15, 2025 • 12 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 One of the All Things Biosimilar Podcast:
U.S. Ustekinumab Biosimilars Market YTD
U.S. Biosimilars Market Survey: Who Do You Think Will Be Leading the Next Decade?
Zarxio Turns 10
Chapters:
00:00 Introduction to the Episode One
01:07 Big Topic 1: US Stelara Biosimilars Market
08:11 Big Topic 2: Survey Results: Top Biosimilar Companies
11:05 Big Topic 3: Zarxio Turns 10
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 (00:01):
On today's episode, we will be looking at
the first six months of the USStelara biosimilars market, see
how competition is setting up,and also look at how the class
is performing.
We'll be reviewing some resultsfrom a survey that all things
biosimilar put out where youtell us who you think some of
the most successful companieshave been in the first 10 years
(00:23):
of the biosimilars market herein the us.
And also who you think will besome of the leaders in the next
10 years.
And finally, a quick happybirthday to Zio, which if you
can believe it turns 10 today.
I'm Andrew Burgo.
I'm your host.
Welcome to the All ThingsBiosimilar podcast.
(00:58):
So welcome to episode one of theAll Things biosimilar podcast.
I'm your host, Andrew Bergo.
Thank you for joining us today.
Our first big topic is the USbiosimilar market for Stelara,
which as many of you know, beganat the beginning of this year
with the launch of what's laa.
And since we've seen many otherbiosimilars come to the market,
(01:20):
the most recent from Accord,which launched their product in
August now.
We're about six months in inearnest since most of the
biosimilars launched in thatlate February to early March
timeline, and we wanted to asktwo questions.
Number one, how is thecompetitive set setting up thus
far?
And number two, how's the classperforming?
(01:44):
So for the competitive overview,we're going to leverage some
alliteration and look at theplayers, the product profiles
and pricing.
Starting with the players, ofcourse, reference product
sponsor here at Johnson andJohnson.
They have actually launched aunbranded version of Stelara.
(02:04):
They did the same thing forRemicade as well, so probably
not a surprise to see it.
Um, and looking at the list ofbiosimilar competitors, a lot of
familiar names.
You have the Amgen, Sandoz,Teva, as well as Fresenius
Biocon, and Celon.
Accord has also launched theirproduct and we are anticipating
(02:28):
Hickma to join the marketplaceas well.
This will be Hickman's firstbiosimilar in the United States.
So from a product profileperspective, we, evaluate in
this in two different ways.
We look at the, status ofinterchangeability.
Does a product have it, are theysitting with exclusivity or not.
And then the second is, lookingat the dose strengths and forms
(02:52):
presentations across thereference product label.
And whether or not biosimilarscarry the same label attributes
with regards to those strengthsand presentations.
Now with Stelara, there's four,right?
They have a 90 and 45 milligramprefilled syringe, a 45
milligram vial, and then also130 milligram vial.
(03:16):
And when you look across thecompetitive set of the
biosimilars, for the most part,all biosimilars have.
All four of these dose strengthsand presentation combinations.
We will note that the Amgen andSandoz biosimilars also have
auto-injectors.
They have 90 and 45 milligramauto-injectors in their label,
(03:36):
although we're unaware that anyof these auto-injector have
entered the marketplace to date.
That being said, when there isquite a bit of parody across the
biosimilar set with regards towhat's in the label.
Having this bit ofdifferentiation could be a
competitive advantage.
(03:58):
Also with interchangeability wasLana was the first to launch
with this designation and theexclusivity period for that ran
out at the end of April.
So.
As you can see, there's a lot ofparody there as well, and with
not a lot of differentiationacross your product profile or
(04:20):
interchangeability.
Then really it's around pricingto be able to find an edge in
this marketplace.
That being said, we're seeingfor the most part some deeper 80
and even 90 plus percentdiscount for the biosimilars
list prices.
(04:41):
So overall looking the PEcompetitive space, again, high
number of competitors, not a lotof differentiation across the
label, or interchangeability atthis point.
But also some pretty aggressivediscounts, at wac.
All right, so that's thebiosimilar class.
The question becomes how wellare they performing?
(05:02):
It's been six months, so this isa good time to check and see if
there's any share capture onbehalf of the biosimilar class.
And so we did analysis andlooked at symphony data,
specifically integrated units.
And measured as a percentage oftotal market share, how well
that cohort of biosimilars aredoing.
(05:22):
The biosimilar class, which hereis represented in dark blue, are
doing against the brand, whichis both Stelara and the
Ustekinumab unbranded version.
And as you can see, there's apretty positive, step up here in
July for the biosimilar class.
And what this tells us is thatin the first six months, this
trend up above 20% sharecapture, is.
(05:45):
Positive for the biosimilarclass.
If you think about kind of thetrend lines for some of the
other biosimilars, specificallythe Humira biosimilars, it took
a little bit longer to get tothat number.
Now, will it continue?
We'll see.
We're actually curious if, uh,potentially that number could be
light.
Is there, um, in fact greaterbiosimilar market share being
(06:07):
captured than, than what we'reseeing here?
And the reason why we ask thatquestion is because in the
Humira biosimilars market, uh,some of the private labels that
are competing and doing quitewell, uh, we have seen no longer
report their data.
So that means that there's.
Sometimes significant sharebiosimilars, um, utilization or
(06:28):
volume that is not beingreported.
And could the same thing behappening in the Stelara market?
I.
Two things likely have to betrue for that to occur.
Number one, uh, biosimilarprivate label deals have to be,
have to exist.
And sure enough, there are, weknow Cord Davis, has, an
Ustekinumab product and as wellas quant and Novea.
(06:51):
The second thing is, are weseeing an overall decline?
In the total volume of theUstekinumab class.
Right.
This is a good indicator for usbecause maybe there is some
share that is just gone.
Right?
It's no longer volume that isbeing reported but is out there.
So we did do a quick peek at theoverall Ustekinumab products.
(07:15):
So this is all volume in theintegrated units data.
And sure enough, starting, afterMarch, you see this decline now?
Sure.
That could be, sure that couldbe, utilization shifting to
other MOAs.
Think about the Tremfya as anexample.
But this also could reflect thefact that there is more
(07:37):
biosimilar competition happeningand there's increased
utilization at some of the.
Private label products that justisn't being captured in the
data.
So what's the take home messagehere for the big topic number
one of episode one?
Stelara biosimilars are doingpretty well, doing pretty well,
so congrats to those companiesand products and we can't wait
(08:00):
to see what the next six monthsholdall right, so big topic
number two.
Today is actually all about you.
That's right.
We're looking at results from asurvey that all things
biosimilar put out at thebeginning of this summer, and we
(08:22):
had about 50 people respond tothis.
It was open to anybody.
It was available via LinkedInfor I think about two months.
And, we aggregated all theinformation and put it into some
slides, and we're gonna look atthree of them today if you're
interested in looking at all theresults.
Please feel free to email us andwe can send you the update.
(08:45):
So the first question that we'llreview is who you thought some
of the most successfulbiosimilar companies have been
over the first decade of thismarket.
We let every respondent selectup to three, and as you can see,
vast majority of you said bothAmgen and Sandoz have been some
(09:05):
of the most commerciallysuccessful biosimilar companies
thus far.
No surprise there, right?
Amgen and Sandoz both have eightor more biosimilars approved.
Most of them are competingsuccessfully in the marketplace,
and if you think about Amgen,they might even have more,
except for the fact that a lotof the reference products
(09:26):
experiencing biosimilarcompetition are Amgen products.
One other thing to highlighthere is seeing Coherus listed.
Of course, they're no longer inbiosimilars, but did play an
important role in the firstdecade of biosimilar
competition.
It was good to see a shout outthere for that company.
Of course, we also then wantedto know why you thought these
(09:48):
companies were successful.
What were some of the attributesof the companies that led them
to commercial success?
And to no surprise here we seeaggressive pricing and
contracting listed up at thetop, as well as early market
entry, as kind of the two keythings that companies had in
order to be successful.
We wanted to call out the factthat biosimilar strategy aligned
(10:10):
with corporate strategy.
And strong internal culture arealso listed as pretty important
attributes for companies thatare finding success in this
marketplace.
Now to the last question that wewanted to highlight, which is
who you thought leaders in theUS biosimilars market will be
for the next decade.
(10:30):
And to no surprise, we see somefamiliar names up at the top if
you're interested in getting thefull recap of the survey
results.
Please reach out to us.
We'll send you what we've puttogether, and thanks for those
who participated.
We really would like to do moresurveys and get your perspective
because those of you that workin this space well, you've got a
(10:54):
lot of great insights and we'dlove to hear from you.
So big topic number three.
Well, big day in history.
That's right.
September 3rd, 2015.
Now, believe it or not, thisisn't just the day that a US
(11:15):
judge overturned.
Tom Brady's four games ofsuspension over to FLA eight.
No.
There's something else thathappened that day, and that's
the fact that the US biosimilarsmarket opened.
That's right.
10 years ago today, Zarziolaunched and like some of you, I
remember where I was when Zarziolaunched and reflecting back.
(11:36):
It's wild to think about howmuch has changed since then.
It's also wild to think thatsome things haven't changed.
This market is still quitechallenging and it likely will
be for the next 10 years.
And it's because some of thesechallenges and the constant
change that exists in thisdynamic marketplace, all things
(11:57):
biosimilar exists.
We try to stay on top ofeverything.
And with this new podcast, wehope that it's another way for
you to stay in touch witheverything that's going on as
well.
So happy birthday, ZZI.
Happy birthday to the USbiosimilars market, and thank
you for listening today to theAll Things Biosimilar podcast.
On today's episode, we will be looking at
the first six months of the USStelara biosimilars market, see
how competition is setting up,and also look at how the class
is performing.
We'll be reviewing some resultsfrom a survey that all things
biosimilar put out where youtell us who you think some of
the most successful companieshave been in the first 10 years
(00:23):
of the biosimilars market herein the us.
And also who you think will besome of the leaders in the next
10 years.
And finally, a quick happybirthday to Zio, which if you
can believe it turns 10 today.
I'm Andrew Burgo.
I'm your host.
Welcome to the All ThingsBiosimilar podcast.
(00:58):
So welcome to episode one of theAll Things biosimilar podcast.
I'm your host, Andrew Bergo.
Thank you for joining us today.
Our first big topic is the USbiosimilar market for Stelara,
which as many of you know, beganat the beginning of this year
with the launch of what's laa.
And since we've seen many otherbiosimilars come to the market,
(01:20):
the most recent from Accord,which launched their product in
August now.
We're about six months in inearnest since most of the
biosimilars launched in thatlate February to early March
timeline, and we wanted to asktwo questions.
Number one, how is thecompetitive set setting up thus
far?
And number two, how's the classperforming?
(01:44):
So for the competitive overview,we're going to leverage some
alliteration and look at theplayers, the product profiles
and pricing.
Starting with the players, ofcourse, reference product
sponsor here at Johnson andJohnson.
They have actually launched aunbranded version of Stelara.
(02:04):
They did the same thing forRemicade as well, so probably
not a surprise to see it.
Um, and looking at the list ofbiosimilar competitors, a lot of
familiar names.
You have the Amgen, Sandoz,Teva, as well as Fresenius
Biocon, and Celon.
Accord has also launched theirproduct and we are anticipating
(02:28):
Hickma to join the marketplaceas well.
This will be Hickman's firstbiosimilar in the United States.
So from a product profileperspective, we, evaluate in
this in two different ways.
We look at the, status ofinterchangeability.
Does a product have it, are theysitting with exclusivity or not.
And then the second is, lookingat the dose strengths and forms
(02:52):
presentations across thereference product label.
And whether or not biosimilarscarry the same label attributes
with regards to those strengthsand presentations.
Now with Stelara, there's four,right?
They have a 90 and 45 milligramprefilled syringe, a 45
milligram vial, and then also130 milligram vial.
(03:16):
And when you look across thecompetitive set of the
biosimilars, for the most part,all biosimilars have.
All four of these dose strengthsand presentation combinations.
We will note that the Amgen andSandoz biosimilars also have
auto-injectors.
They have 90 and 45 milligramauto-injectors in their label,
(03:36):
although we're unaware that anyof these auto-injector have
entered the marketplace to date.
That being said, when there isquite a bit of parody across the
biosimilar set with regards towhat's in the label.
Having this bit ofdifferentiation could be a
competitive advantage.
(03:58):
Also with interchangeability wasLana was the first to launch
with this designation and theexclusivity period for that ran
out at the end of April.
So.
As you can see, there's a lot ofparody there as well, and with
not a lot of differentiationacross your product profile or
(04:20):
interchangeability.
Then really it's around pricingto be able to find an edge in
this marketplace.
That being said, we're seeingfor the most part some deeper 80
and even 90 plus percentdiscount for the biosimilars
list prices.
(04:41):
So overall looking the PEcompetitive space, again, high
number of competitors, not a lotof differentiation across the
label, or interchangeability atthis point.
But also some pretty aggressivediscounts, at wac.
All right, so that's thebiosimilar class.
The question becomes how wellare they performing?
(05:02):
It's been six months, so this isa good time to check and see if
there's any share capture onbehalf of the biosimilar class.
And so we did analysis andlooked at symphony data,
specifically integrated units.
And measured as a percentage oftotal market share, how well
that cohort of biosimilars aredoing.
(05:22):
The biosimilar class, which hereis represented in dark blue, are
doing against the brand, whichis both Stelara and the
Ustekinumab unbranded version.
And as you can see, there's apretty positive, step up here in
July for the biosimilar class.
And what this tells us is thatin the first six months, this
trend up above 20% sharecapture, is.
(05:45):
Positive for the biosimilarclass.
If you think about kind of thetrend lines for some of the
other biosimilars, specificallythe Humira biosimilars, it took
a little bit longer to get tothat number.
Now, will it continue?
We'll see.
We're actually curious if, uh,potentially that number could be
light.
Is there, um, in fact greaterbiosimilar market share being
(06:07):
captured than, than what we'reseeing here?
And the reason why we ask thatquestion is because in the
Humira biosimilars market, uh,some of the private labels that
are competing and doing quitewell, uh, we have seen no longer
report their data.
So that means that there's.
Sometimes significant sharebiosimilars, um, utilization or
(06:28):
volume that is not beingreported.
And could the same thing behappening in the Stelara market?
I.
Two things likely have to betrue for that to occur.
Number one, uh, biosimilarprivate label deals have to be,
have to exist.
And sure enough, there are, weknow Cord Davis, has, an
Ustekinumab product and as wellas quant and Novea.
(06:51):
The second thing is, are weseeing an overall decline?
In the total volume of theUstekinumab class.
Right.
This is a good indicator for usbecause maybe there is some
share that is just gone.
Right?
It's no longer volume that isbeing reported but is out there.
So we did do a quick peek at theoverall Ustekinumab products.
(07:15):
So this is all volume in theintegrated units data.
And sure enough, starting, afterMarch, you see this decline now?
Sure.
That could be, sure that couldbe, utilization shifting to
other MOAs.
Think about the Tremfya as anexample.
But this also could reflect thefact that there is more
(07:37):
biosimilar competition happeningand there's increased
utilization at some of the.
Private label products that justisn't being captured in the
data.
So what's the take home messagehere for the big topic number
one of episode one?
Stelara biosimilars are doingpretty well, doing pretty well,
so congrats to those companiesand products and we can't wait
(08:00):
to see what the next six monthsholdall right, so big topic
number two.
Today is actually all about you.
That's right.
We're looking at results from asurvey that all things
biosimilar put out at thebeginning of this summer, and we
(08:22):
had about 50 people respond tothis.
It was open to anybody.
It was available via LinkedInfor I think about two months.
And, we aggregated all theinformation and put it into some
slides, and we're gonna look atthree of them today if you're
interested in looking at all theresults.
Please feel free to email us andwe can send you the update.
(08:45):
So the first question that we'llreview is who you thought some
of the most successfulbiosimilar companies have been
over the first decade of thismarket.
We let every respondent selectup to three, and as you can see,
vast majority of you said bothAmgen and Sandoz have been some
(09:05):
of the most commerciallysuccessful biosimilar companies
thus far.
No surprise there, right?
Amgen and Sandoz both have eightor more biosimilars approved.
Most of them are competingsuccessfully in the marketplace,
and if you think about Amgen,they might even have more,
except for the fact that a lotof the reference products
(09:26):
experiencing biosimilarcompetition are Amgen products.
One other thing to highlighthere is seeing Coherus listed.
Of course, they're no longer inbiosimilars, but did play an
important role in the firstdecade of biosimilar
competition.
It was good to see a shout outthere for that company.
Of course, we also then wantedto know why you thought these
(09:48):
companies were successful.
What were some of the attributesof the companies that led them
to commercial success?
And to no surprise here we seeaggressive pricing and
contracting listed up at thetop, as well as early market
entry, as kind of the two keythings that companies had in
order to be successful.
We wanted to call out the factthat biosimilar strategy aligned
(10:10):
with corporate strategy.
And strong internal culture arealso listed as pretty important
attributes for companies thatare finding success in this
marketplace.
Now to the last question that wewanted to highlight, which is
who you thought leaders in theUS biosimilars market will be
for the next decade.
(10:30):
And to no surprise, we see somefamiliar names up at the top if
you're interested in getting thefull recap of the survey
results.
Please reach out to us.
We'll send you what we've puttogether, and thanks for those
who participated.
We really would like to do moresurveys and get your perspective
because those of you that workin this space well, you've got a
(10:54):
lot of great insights and we'dlove to hear from you.
So big topic number three.
Well, big day in history.
That's right.
September 3rd, 2015.
Now, believe it or not, thisisn't just the day that a US
(11:15):
judge overturned.
Tom Brady's four games ofsuspension over to FLA eight.
No.
There's something else thathappened that day, and that's
the fact that the US biosimilarsmarket opened.
That's right.
10 years ago today, Zarziolaunched and like some of you, I
remember where I was when Zarziolaunched and reflecting back.
(11:36):
It's wild to think about howmuch has changed since then.
It's also wild to think thatsome things haven't changed.
This market is still quitechallenging and it likely will
be for the next 10 years.
And it's because some of thesechallenges and the constant
change that exists in thisdynamic marketplace, all things
(11:57):
biosimilar exists.
We try to stay on top ofeverything.
And with this new podcast, wehope that it's another way for
you to stay in touch witheverything that's going on as
well.
So happy birthday, ZZI.
Happy birthday to the USbiosimilars market, and thank
you for listening today to theAll Things Biosimilar podcast.
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.