December 4, 2023 • 25 mins
In this episode of The Community Check-In, Eugene Rozenblyum, Senior Director of Trade Relations and Enterprise Drug Solutions at Excellus BlueCross BlueShield, explores the world of biosimilars—a category of drugs that has emerged in the last decade, offering potentially lower-cost alternatives to biologics. He addresses common questions about biosimilars, including their availability globally, the involvement of major pharmaceutical companies like Pfizer and Amgen and the existence of patient assistance programs to alleviate cost concerns.
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(00:03):
Welcome to excel Us Blue Cross BlueShields Community check In. Each week we
cover a specific topic featuring excel UsBlue Cross Blue Shield experts. You'll get
to know our team as we discussthe latest in healthcare, health education,
and community health. Find us atexcel USBCBS dot com and follow on Instagram
(00:26):
and Facebook. I'm Joel Demonico andwelcome to the Community check In. The
Cost of drugs today can be quiteprohibitive for many patients, those especially with
chronic diseases like kidney conditions, arthritis, IBS. Those people who need ongoing
maintenance medications, they are impacted evenmore. A type of drug category which
(00:47):
you might have heard of, it'scalled biosimilars, have been growing on the
scene for about the last decade orso and are increasing access to life saving
medications at potentially lower costs. Hereto help us understand more of out what
biosimilars are and how they're being usedis pharmacist Eugene Rosenbloom. Eugene, Welcome
to the Community check In. Thankyou, Joe, I appreciate you having
me on today. Eugene is thesenior director of Trade Relations and Enterprise drug
(01:11):
Solutions at Excell's Blue Cross Blue Shield. He competed a farm deal at the
University of Buffalo School of Pharmacy andPharmaceutical Scientists. He's been with Excellis Blue
Cross Blue Shield for about ten years. I'm going to be the dumb guy
in this conversation because I've heard ofthe term that we're going to be talking
about, but I don't know muchabout it. So I want to start
very simply by letting us know.When you speak of a biologic, could
(01:34):
you please explain to us what weare talking about. Absolutely, Joe,
that's the main question here. Soa biologic or biologic drug is a medicine
made from natural materials or living cells. So, for example, materials could
come from yeast, bacteria, oranimal cells. They are highly complex drugs,
(01:57):
and since natural materials have some variabilityiologicsthe variability will be extremely small,
but it doesn't mean you can't createan exact replica. And biologics are used
to treat a wide range of conditions, including cancer, severe allergies, and
autoimmune diseases. And another name that'smaybe some members might have heard of is
(02:21):
also the term specialty medications. Theterms are often used interchangeably. Okay,
good, So at least we knowwhat we're talking about. It it may
increase the number of people who haveheard about what our topic is this week.
So we're going to be talking aboutbiosimilars, Can you please tell us
a little bit more about the conversationwe're going to have on that and what
this category or class of medications are. Sure, so, biosimilars are like
(02:42):
original biological medications, but they arenot identical. And I mentioned biologics are
made from natural materials, and thatmeans that there will be a tiny amount
of variability in the product. Soa biosimilar cannot be an exact copy.
Instead, biosimilars mimic the act ofingredients in the biologic drug it's trying to
replicate now. Now, in orderto get approval from the FDA, a
(03:06):
biosimilar needs to have no clinically meaningfuldifferences from the reference biologic and it has
to provide the same benefit in treatinga patient's medical condition or disease. So
essentially, the outcome of a biosimilarneeds to be the same as that of
the biologic. And when a biologicdrugs patent expires, that's when other companies
(03:27):
are able to develop biosimilars, increasingoptions that are available in the marketplace.
Okay, so then by increasing someaccess to the drug and potentially lowering the
cost. When we think about thelower cost medication, those on the outside,
like myself often think of generic drugsand generic drugs being at a lower
(03:47):
cost point than their brand name counterpartsthat may do exactly the same thing.
Are biosimilars then, like generic drugs, Yeah, that's a great question,
Joe. So they're similar but notthe same. A generic drug uses identical
main ingredients to the brand name drugs. Biosimilars, as I mentioned, are
(04:10):
large, complex molecules produced from livingorganisms that have shown to work the same
way in the body as a biologic. So they are similar in the fact
that both generics and biosimilars we're introducedin the market to increase competition, reduce
costs, and improve patient access tomedications that are needed. The way I
like to think about it in termsof complexity when you're developing a biologic or
(04:33):
biosimilar compared to a traditional medication ora generic is if you think about a
drug such as your typical medication usedfor blood pressure for your thyroid or an
antibiotic like a maxicillin. That's equivalentto building a bike. Now there are
some more complex traditional medications, suchas those used for multiple sclerosis, and
(04:55):
that's more like building a car.But when we're talking about biologics or biol
similars, those are the equivalent ofbuilding a space shuttle, so they're significantly
more complex. So, based onwhat you know of these, was the
idea behind biosimilars being created. Wasthe initial thought to come at a problem
i e. Treating a disease froma new way or was it from what
(05:19):
you understand of it was it merelyfor cost saving and accessibility. So I
think it's a little bit of both. Certainly, these drugs are some of
the costliest drugs available, and sowhenever you have increased competition that helps lower
the price and can help our membersin the community get the medications that they
(05:41):
need. Of course, having accessis highly critical, especially with the ongoing
maintenance drugs or as you mentioned,say multiple sclerosis or a cancer drug.
It can be the very difference betweensomebody having a good long quality of life
in someone's life potentially ending far toosoon. But again, red flags start
to go up. When we starthearing bio anything, it's about the safety
(06:02):
factor. It's about what's in thisand is this safe to be taking.
So I'll put it to your pointblank. Are biosimilar safe for people to
be using on a regular basis?Yes, biosimilars are safe. The FDA
requires rigorous testing and evaluation before abiosimilar is approved, so patients and health
care providers can be confident in thesafety and effectiveness of these products. And
(06:27):
actually, when you compare the amountof testing that a biosimilar requires compared to
a generic, it's more testing bythe FDA. Any indication as to why
that would be why the FDA pensa little bit more attention to that,
Is it just because of the natureof the class of drug. Yes,
So when you're looking at a traditionalmedication with a generic, the generic manufacturer
(06:49):
just has to prove that when youtake the generic medication, the levels in
the blood are equivalent to levels ofthe brain and the product. Now,
for biosimilars, in addition to lookingat the levels in the bloodstream, there's
also additional full blown studies that thebiosimilar manufacturer has to do to prove that
(07:15):
they're actually works the way it's supposedto work, and the safety profile is
similar to that of the drug thatit's being compared to, so that there's
more testing than a generic medication.Okay, so they essentially have a slightly
higher standard maybe that they have tomeet before that goes to market. Eugene
Rosenblum is our guest on the CommunityCheck In this week, Senior director of
(07:35):
Trade Relations and Enterprise drug Solutions atexcel As Blue Cross Blue Shield. We're
talking about a class of medications youmight have heard of. They're called biosimilars.
And now that we have a littlebit of an understanding, and really
he's gone to school, so he'scooling us this week, we have an
understanding of some of the terms thatwe're going to be discussing as we continue
with the program. Eugene, helpus understand why biosimilars exist. That's question
(07:58):
number one. Number two. Whyare they beneficial? Why is this class
of medication then proving to be sucha vital tool in the ongoing maintenance or
in the battling of some complex diseases. Absolutely so. Biologics are typically some
of the most innovative drugs that areused to treat serious medical conditions, but
(08:18):
they are also the costliest category ofdrugs. So there are many drugs that
can cost anywhere from fifty thousand dollarsto over a million dollars a year to
the health plan. So when youthink about that, that's like buying a
car or several houses every single year. So this high price deck can limit
(08:39):
accessibility for patients who need the medicationsthe most. So, as I mentioned,
biosimilars were introduced to increased competition andthereby increasing the number of drugs on
the market, increasing access to thosemedications, and thereby reducing costs. And
so even though the lead time todeveloping a biosimilar can take years, the
cost of developing the biosimilars is oftenless than that of the biologic and this
(09:05):
can be because much of the updevelopmental costs have already been completed, so
they're basing the drug and the existingbiologic. So biosimilar still need to go
through that extensive thorough testing to ensurethey're safe and effective, but because of
those reasons, they may not costas much as creating a new drug from
scratch. So are the manufacturers thenable to take some of the work and
(09:28):
some of the research and data thathas already been done and they use that
as essentially a starting point or areference point that they will be using then
to create the similar version of thatbiologic that can then go through its own
set of testing. Absolutely, youcan think of it that they already have
a blueprint that they can start with, so a lot of the time and
(09:50):
money involved in developing that has alreadybeen accomplished. And then as I mentioned,
they just need to do the clinicalstudies that the FDA is involved in
and overseas to make sure that thedrugs are safe and effective. When you
mentioned some of the costs involved here, and that is a conversation of course,
for another day, but there's awide range and some of these can
(10:13):
be very expensive in their biologic standard. Talk to me about from Excel's Blue
Cross Blue Shields perspective, as ahealth insurance company, why would they want
to be in this game and wantingmaybe more biosimilars to be on the market
and more available so that patients cannow have options that are going to be
(10:35):
not only beneficial to them but alsosave them at the same time, save
the dollars I mean at the sametime. Yeah, more and more biosimilar
for gaining FD approval and coming onthe market. So increasing access to high
quality, affordable healthcare is our mission, so it makes sense to explore drugs
like this that can help increase accessto these very important life saving medications.
(10:58):
So there're three approved biosimilars that areon the market, and there's over one
hundred in development right now. Sowe closely monitor the market and know when
biologics are coming off patent and thenwe get to work adding coverage for biosimilars
as quickly as we can, butwe only do that after an extensive clinical
(11:20):
review from our clinical teams, andwe also work very closely with our provider
community to make sure they're on boardwith our recommendations. When you mentioned there
are currently forty three on the market, I would suspect the process isn't necessarily
quick when it comes to bringing moreonto the market. As you mentioned,
maybe some has to come off patentso that that information can then be made
(11:43):
more public so that a company canthen put the research and development into making
more. Is it a slow processto bring a new one to the market.
It's certainly takes some time. Sothey are actually more than forty three
currently approved by the FDA, butbecause a patent litication, they can't launch
and be available to be sold untilyears down the line. So you have
(12:07):
some twenty twenty five, you havesome in twenty twenty nine, So technically
they're already approved by the FDA.They've been shown from a clinical perspective be
safe and effective, but because ofthat patent litigation, they can't be released
in soldient. I have to bepatient for it, I suppose. So
I like to hear stories and Ilike to hear about them because they help
(12:28):
me understand how it can work andhave real world applications. If you could
give us, please an example ofhow a biosimilar is now maybe a preferred
drug, and how it got frompoint A to point B. Oh.
Sure. So some people may befamiliar with a biologic drug called hume Era.
It helps treats various autoimmune diseases suchas Crohn's disease or rheumatridathritis, plaque
(12:56):
psoriasis, irritable Biel disease, andKumera is one of the biggest selling medications
of all time, the number onedrug in the world, with global sales
exceeding twenty one billion. Dollars.In twenty twenty two and this year,
some biosimilars became available to Humera,and the list price for this type of
(13:20):
medication could be several thousand dollars perpation per month. And so when two
new biosimilars, so Teslo and headLima were approved by the DA to treat
the same diseases as Humera, weadded those drugs to our preferred treatment options
in addition to Kumeera. So addingthese options to a preferred list gives members
(13:41):
who need this type of drug moreof a choice and to help lower costs.
Eugene Rosenbloom is Senior director of TradeRelations and Enterprise drug Solutions that excel
Us Blue Cross Blue Shield. We'lltalk more about biosimilars where the community check
in continues for everybody who believes thecare they deserve should always be within reach,
for everybody who wants to be confidentabout insurance for the next phase in
(14:03):
life, for everybody who's looking forthe best way is to take care of
their employees and their families. AtExcell's Blue Cross Blue Shield, we're making
care more accessible and affordable in moreways and for more people in our community,
because when we do that, everybodybenefits. Learn more at EXCELSBCBS dot
com. I'm Joelmonica. Welcome backto the Community check In. Our guest
(14:26):
is Eugene Rosenbloom, Senior Director ofTrade Relations and Enterprise drug Solutions at Excell's
Blue Cross Blue Shield. We're talkingabout a class of medications called biosimilars on
this week's community check in. Aswe just mentioned, you might have even
you might even be on one atthis point because of the popularity of that
drug that you just met, ofhume Era, and I've heard of that,
(14:48):
I've seen a lot of that.Let's recap just some of those numbers.
Currently, Excell's Blue Cross Blue Shieldis actively covering how many biosimilars that
are available on the market, allof them. So there are currently forty
three FT approved biosimilars on the market. And at Excels we have preferred biosimilars
(15:11):
in all ten of the specific drugcategories that biosimilars are available in, and
some examples include oncology, support oficology care, inflammatory disease, insulin eye
diseases. So we have preferred optionsfor biosimilars in all ten of those drug
(15:31):
categories, and I would suspect allof those categories have medications on it that
are probably substantial in cost. Isthat correct? Absolutely, all of these
medications are very expensive. Okay,And I know you mentioned insulin in there,
and that's just one. We canspend an entire show just talking about
the availability and what has happened inthat category alone that has really drawn some
(15:54):
attention to this category. Refresh usagain. It takes about how long for
a biosimilar to actually come into themarketplace after it's gone through its extensive due
diligence, when the patent comes offand they can actually start looking at the
sort of blueprint to make that biosimilar. Yeah, so it takes years.
(16:15):
So the first major hurdle is thepatent. So once the patent life is
over and manufacturers of the original biologicmight have a pen for ten or more
years, so it takes a longtime for that patent to go away and
be resolved. And so then youtake the biosimilars which need to be reverse
(16:37):
engineered, and then you have tocomplete the clinical studies so they must have
the same clinical effectiveness and safety profileas that reference drug, and so they
can be used to treat the sameconditions, and the manufacturer must also demonstrate
that its product has no clinically meaningfuldifferences. That's very important, which to
(17:00):
show that it works similarly in thebody. So you're talking about safety,
you're talking about purity, you're talkingabout potency. So even though it may
take less time overall compared to aregular biologic, it still takes time to
develop because, as I mentioned earlier, producing biologic and biosimilars, it's like
building a spaceship. It's highly complexproducts. You mentioned reverse engineering, the
(17:25):
frontiers that science is able to do, and how they're able to come up
with answers to these complex problems.I mean, you look at some medications
throughout history and some categories or classesof medication and how many decades it may
have taken to do the research.Just quickly, in your observation, is
science accelerating because of the tools thatare available to them now? And we're
(17:48):
not just talking about you know,you know, medications that currently exist and
then research that can be done basedon other people's work, But is the
pace at wheen which some of thisreverse engineering can happen. Are you seeing
it accelerating because of the tools thatare available. Oh, certainly with scientific
advancement, it's amazing that the typesof treatments available. So when you're looking
(18:12):
at different disease states, there's somany different options now available. So you
know, decades ago, when youtake something like blood pressure, there might
have been two drugs available. Nowthere's you know, over twenty drugs available
to treat blood pressure. But Ithink really the most advancement has come in
those rare diseases where previously there wasno treatment option at all, and there
(18:38):
was nothing that can be done forthese unfortunate patients. And now with advancement
and medical technology, there are drugsused to treat a lot of these rare
conditions. A lot of these aregenetic conditions that you're bored with, and
so we've got great medications now availableto help more and more patients who need
them. Who's getting in the game. Are all the players getting into the
(19:00):
biosimilar game? Yeah, so,Joe. Anytime you turn on the TV
or read a magazine, you're goingto see an ad from a drug manufacturer,
and those same large manufacturers are oftenmaking the biosimilars. So just a
few examples of some names you mighthave heard of our Fizer, am gine
saandtos Milin, and there's many morewho are making these biosimilar medications. And
(19:25):
our manufacturers stepping up to offer anykind of patient assistance. I know some
manufacturers or some medications will offer thatsay, if you need help paying for
it, we do have some availabilitythere is in this space. Our manufacturers
stepping up, Oh absolutely. Somanufacturers often offer these patient assistance programs or
(19:45):
you may call them coupid cards,and most biosimilar manufacturers have the same or
even better than compared to the otherbrand biologic manufacturer. So those will help
offset members out of poplict costs forthose types of medications. And so you
can just go on on the websiteand look for those specific drugs to find
(20:07):
those manufacturer systems programs, or ifyou need help, certainly consult with your
doctor pharmacist. Eugene Rosenbloom is Seniordirector of Trade Relations and Enterprise drug Solutions
at Excell's Blue Cross Blue Shield.We'll talk more about biosimilars where the community
check in continues for everybody who believesthe care they deserve should always be within
reach for everybody who wants to beconfident about insurance for the next phase in
(20:32):
life, for everybody who's looking forthe best ways to take care of their
employees and their families. At Excell'sBlue Cross Blue Shield, we're making care
more accessible and affordable in more waysand for more people in our community,
because when we do that, everybodybenefits. Learn more at EXCEL'SBCBS dot com.
I'm Joelmonica. Welcome back to theCommunity check in. Our guest is
(20:56):
Eugene Rosenbloom, Senior director of TradeRelations and Enterprise drug Solutions that Excel as
Blue Cross Blue Shield. We've beentalking in this community check in about biosimilars.
It is about a specific category orclass of drug. Are they only
available in the US or is thisa global availability for these drugs or are
there different types of them that areavailable in different corners of the world.
(21:18):
That's a great question. So they'reavailable globally, So Europe has had them
since two thousand and six, Canadasince two thousand and nine. So Europe
and Canada are ahead of the USin that area. And we can look
at these countries and learn from theirsuccesses instituting and sustaining a biosimilar market over
the last decade, and by learningand leveraging what other countries have done,
(21:42):
it helps prove that biosimilars are equallysafe, effective, and lower cost alternatives
to specialty biologics. Because of thefact that so much has to happen with
research and testing and data driven herein the United States. Has that put
us in a place where I don'twant to say we're behind everyone, but
(22:06):
are we just doing things here inthe United States the way we know it's
best for us to do for ourpopulation and putting the steps through biosimilars to
make sure that they're ready for market. Well, other countries also require extensive
clinical testing for biosimilar So I thinkit's just with different regulations and legislation that
(22:27):
the US is a is a littleslower to embrace these. But we're here
now and that's the important thing,and we can move forward and have these
options available for our members. Andas we get ready to wrap up our
conversation here this week, what domembers need to know about what's available and
(22:48):
how they need to have productive conversationswith their healthcare team about maybe a drug
in this category or class is goingto be right for them. Absolutely,
so biosimilars may help you save significantlyand increase access to medicines. When we're
looking at the price, some biosolersare eighty five percent less expensive than their
brand counterpart, so it's a significantdifference. So if you're in a biologic
(23:14):
medication, talk to your doctor orhealthcare professional to see if biosimilars are available
and are appropriate for you. EugeneRosenbloom is the senior director of Trade Relations
and Enterprise drug Solutions at excel AsBlue Cross, Blue Shield. Eugene in
our final two minutes of the programtoday, we've talked a lot about the
advancements in medication, how biosimilars arereducing costs, often substantially. We're talking
(23:37):
about increasing access. So they're doinga lot of good. Bottom line for
you from where you sit, whatare you looking forward to with potentially excitement
about the doors that this category ofmedication are going to be able to open
up in the near and long term. Yeah, it definitely opens up opportunit
(24:00):
comunities for members in our community wherehealthcare costs are very important to them.
So having lower priced options that workjust as well is a great benefit to
our community, and we would liketo see hopefully more advancements in this as
time progresses, opening up additional categoriesand helping reduce costs so that can be
(24:21):
again better outcomes, longer term outcomes, patients having better quality of life for
longer Eugene Rosenbloom, thank you somuch for spending time with us on this
community check in and getting us behindthe scenes of biosimilars. Thank you,
Joe, appreciate it. Thanks forjoining us on Community check in. A
presentation of excel Us Blue Cross BlueShield at iHeartRadio. Podcasts of Community check
(24:44):
In are available on the iHeartRadio appor wherever you find your favorite audio content.
For more ways to stay safe,healthy and educated, visit excel USBCBS
dot com and follow on Instagram andFacebook
Welcome to excel Us Blue Cross BlueShields Community check In. Each week we
cover a specific topic featuring excel UsBlue Cross Blue Shield experts. You'll get
to know our team as we discussthe latest in healthcare, health education,
and community health. Find us atexcel USBCBS dot com and follow on Instagram
(00:26):
and Facebook. I'm Joel Demonico andwelcome to the Community check In. The
Cost of drugs today can be quiteprohibitive for many patients, those especially with
chronic diseases like kidney conditions, arthritis, IBS. Those people who need ongoing
maintenance medications, they are impacted evenmore. A type of drug category which
(00:47):
you might have heard of, it'scalled biosimilars, have been growing on the
scene for about the last decade orso and are increasing access to life saving
medications at potentially lower costs. Hereto help us understand more of out what
biosimilars are and how they're being usedis pharmacist Eugene Rosenbloom. Eugene, Welcome
to the Community check In. Thankyou, Joe, I appreciate you having
me on today. Eugene is thesenior director of Trade Relations and Enterprise drug
(01:11):
Solutions at Excell's Blue Cross Blue Shield. He competed a farm deal at the
University of Buffalo School of Pharmacy andPharmaceutical Scientists. He's been with Excellis Blue
Cross Blue Shield for about ten years. I'm going to be the dumb guy
in this conversation because I've heard ofthe term that we're going to be talking
about, but I don't know muchabout it. So I want to start
very simply by letting us know.When you speak of a biologic, could
(01:34):
you please explain to us what weare talking about. Absolutely, Joe,
that's the main question here. Soa biologic or biologic drug is a medicine
made from natural materials or living cells. So, for example, materials could
come from yeast, bacteria, oranimal cells. They are highly complex drugs,
(01:57):
and since natural materials have some variabilityiologicsthe variability will be extremely small,
but it doesn't mean you can't createan exact replica. And biologics are used
to treat a wide range of conditions, including cancer, severe allergies, and
autoimmune diseases. And another name that'smaybe some members might have heard of is
(02:21):
also the term specialty medications. Theterms are often used interchangeably. Okay,
good, So at least we knowwhat we're talking about. It it may
increase the number of people who haveheard about what our topic is this week.
So we're going to be talking aboutbiosimilars, Can you please tell us
a little bit more about the conversationwe're going to have on that and what
this category or class of medications are. Sure, so, biosimilars are like
(02:42):
original biological medications, but they arenot identical. And I mentioned biologics are
made from natural materials, and thatmeans that there will be a tiny amount
of variability in the product. Soa biosimilar cannot be an exact copy.
Instead, biosimilars mimic the act ofingredients in the biologic drug it's trying to
replicate now. Now, in orderto get approval from the FDA, a
(03:06):
biosimilar needs to have no clinically meaningfuldifferences from the reference biologic and it has
to provide the same benefit in treatinga patient's medical condition or disease. So
essentially, the outcome of a biosimilarneeds to be the same as that of
the biologic. And when a biologicdrugs patent expires, that's when other companies
(03:27):
are able to develop biosimilars, increasingoptions that are available in the marketplace.
Okay, so then by increasing someaccess to the drug and potentially lowering the
cost. When we think about thelower cost medication, those on the outside,
like myself often think of generic drugsand generic drugs being at a lower
(03:47):
cost point than their brand name counterpartsthat may do exactly the same thing.
Are biosimilars then, like generic drugs, Yeah, that's a great question,
Joe. So they're similar but notthe same. A generic drug uses identical
main ingredients to the brand name drugs. Biosimilars, as I mentioned, are
(04:10):
large, complex molecules produced from livingorganisms that have shown to work the same
way in the body as a biologic. So they are similar in the fact
that both generics and biosimilars we're introducedin the market to increase competition, reduce
costs, and improve patient access tomedications that are needed. The way I
like to think about it in termsof complexity when you're developing a biologic or
(04:33):
biosimilar compared to a traditional medication ora generic is if you think about a
drug such as your typical medication usedfor blood pressure for your thyroid or an
antibiotic like a maxicillin. That's equivalentto building a bike. Now there are
some more complex traditional medications, suchas those used for multiple sclerosis, and
(04:55):
that's more like building a car.But when we're talking about biologics or biol
similars, those are the equivalent ofbuilding a space shuttle, so they're significantly
more complex. So, based onwhat you know of these, was the
idea behind biosimilars being created. Wasthe initial thought to come at a problem
i e. Treating a disease froma new way or was it from what
(05:19):
you understand of it was it merelyfor cost saving and accessibility. So I
think it's a little bit of both. Certainly, these drugs are some of
the costliest drugs available, and sowhenever you have increased competition that helps lower
the price and can help our membersin the community get the medications that they
(05:41):
need. Of course, having accessis highly critical, especially with the ongoing
maintenance drugs or as you mentioned,say multiple sclerosis or a cancer drug.
It can be the very difference betweensomebody having a good long quality of life
in someone's life potentially ending far toosoon. But again, red flags start
to go up. When we starthearing bio anything, it's about the safety
(06:02):
factor. It's about what's in thisand is this safe to be taking.
So I'll put it to your pointblank. Are biosimilar safe for people to
be using on a regular basis?Yes, biosimilars are safe. The FDA
requires rigorous testing and evaluation before abiosimilar is approved, so patients and health
care providers can be confident in thesafety and effectiveness of these products. And
(06:27):
actually, when you compare the amountof testing that a biosimilar requires compared to
a generic, it's more testing bythe FDA. Any indication as to why
that would be why the FDA pensa little bit more attention to that,
Is it just because of the natureof the class of drug. Yes,
So when you're looking at a traditionalmedication with a generic, the generic manufacturer
(06:49):
just has to prove that when youtake the generic medication, the levels in
the blood are equivalent to levels ofthe brain and the product. Now,
for biosimilars, in addition to lookingat the levels in the bloodstream, there's
also additional full blown studies that thebiosimilar manufacturer has to do to prove that
(07:15):
they're actually works the way it's supposedto work, and the safety profile is
similar to that of the drug thatit's being compared to, so that there's
more testing than a generic medication.Okay, so they essentially have a slightly
higher standard maybe that they have tomeet before that goes to market. Eugene
Rosenblum is our guest on the CommunityCheck In this week, Senior director of
(07:35):
Trade Relations and Enterprise drug Solutions atexcel As Blue Cross Blue Shield. We're
talking about a class of medications youmight have heard of. They're called biosimilars.
And now that we have a littlebit of an understanding, and really
he's gone to school, so he'scooling us this week, we have an
understanding of some of the terms thatwe're going to be discussing as we continue
with the program. Eugene, helpus understand why biosimilars exist. That's question
(07:58):
number one. Number two. Whyare they beneficial? Why is this class
of medication then proving to be sucha vital tool in the ongoing maintenance or
in the battling of some complex diseases. Absolutely so. Biologics are typically some
of the most innovative drugs that areused to treat serious medical conditions, but
(08:18):
they are also the costliest category ofdrugs. So there are many drugs that
can cost anywhere from fifty thousand dollarsto over a million dollars a year to
the health plan. So when youthink about that, that's like buying a
car or several houses every single year. So this high price deck can limit
(08:39):
accessibility for patients who need the medicationsthe most. So, as I mentioned,
biosimilars were introduced to increased competition andthereby increasing the number of drugs on
the market, increasing access to thosemedications, and thereby reducing costs. And
so even though the lead time todeveloping a biosimilar can take years, the
cost of developing the biosimilars is oftenless than that of the biologic and this
(09:05):
can be because much of the updevelopmental costs have already been completed, so
they're basing the drug and the existingbiologic. So biosimilar still need to go
through that extensive thorough testing to ensurethey're safe and effective, but because of
those reasons, they may not costas much as creating a new drug from
scratch. So are the manufacturers thenable to take some of the work and
(09:28):
some of the research and data thathas already been done and they use that
as essentially a starting point or areference point that they will be using then
to create the similar version of thatbiologic that can then go through its own
set of testing. Absolutely, youcan think of it that they already have
a blueprint that they can start with, so a lot of the time and
(09:50):
money involved in developing that has alreadybeen accomplished. And then as I mentioned,
they just need to do the clinicalstudies that the FDA is involved in
and overseas to make sure that thedrugs are safe and effective. When you
mentioned some of the costs involved here, and that is a conversation of course,
for another day, but there's awide range and some of these can
(10:13):
be very expensive in their biologic standard. Talk to me about from Excel's Blue
Cross Blue Shields perspective, as ahealth insurance company, why would they want
to be in this game and wantingmaybe more biosimilars to be on the market
and more available so that patients cannow have options that are going to be
(10:35):
not only beneficial to them but alsosave them at the same time, save
the dollars I mean at the sametime. Yeah, more and more biosimilar
for gaining FD approval and coming onthe market. So increasing access to high
quality, affordable healthcare is our mission, so it makes sense to explore drugs
like this that can help increase accessto these very important life saving medications.
(10:58):
So there're three approved biosimilars that areon the market, and there's over one
hundred in development right now. Sowe closely monitor the market and know when
biologics are coming off patent and thenwe get to work adding coverage for biosimilars
as quickly as we can, butwe only do that after an extensive clinical
(11:20):
review from our clinical teams, andwe also work very closely with our provider
community to make sure they're on boardwith our recommendations. When you mentioned there
are currently forty three on the market, I would suspect the process isn't necessarily
quick when it comes to bringing moreonto the market. As you mentioned,
maybe some has to come off patentso that that information can then be made
(11:43):
more public so that a company canthen put the research and development into making
more. Is it a slow processto bring a new one to the market.
It's certainly takes some time. Sothey are actually more than forty three
currently approved by the FDA, butbecause a patent litication, they can't launch
and be available to be sold untilyears down the line. So you have
(12:07):
some twenty twenty five, you havesome in twenty twenty nine, So technically
they're already approved by the FDA.They've been shown from a clinical perspective be
safe and effective, but because ofthat patent litigation, they can't be released
in soldient. I have to bepatient for it, I suppose. So
I like to hear stories and Ilike to hear about them because they help
(12:28):
me understand how it can work andhave real world applications. If you could
give us, please an example ofhow a biosimilar is now maybe a preferred
drug, and how it got frompoint A to point B. Oh.
Sure. So some people may befamiliar with a biologic drug called hume Era.
It helps treats various autoimmune diseases suchas Crohn's disease or rheumatridathritis, plaque
(12:56):
psoriasis, irritable Biel disease, andKumera is one of the biggest selling medications
of all time, the number onedrug in the world, with global sales
exceeding twenty one billion. Dollars.In twenty twenty two and this year,
some biosimilars became available to Humera,and the list price for this type of
(13:20):
medication could be several thousand dollars perpation per month. And so when two
new biosimilars, so Teslo and headLima were approved by the DA to treat
the same diseases as Humera, weadded those drugs to our preferred treatment options
in addition to Kumeera. So addingthese options to a preferred list gives members
(13:41):
who need this type of drug moreof a choice and to help lower costs.
Eugene Rosenbloom is Senior director of TradeRelations and Enterprise drug Solutions that excel
Us Blue Cross Blue Shield. We'lltalk more about biosimilars where the community check
in continues for everybody who believes thecare they deserve should always be within reach,
for everybody who wants to be confidentabout insurance for the next phase in
(14:03):
life, for everybody who's looking forthe best way is to take care of
their employees and their families. AtExcell's Blue Cross Blue Shield, we're making
care more accessible and affordable in moreways and for more people in our community,
because when we do that, everybodybenefits. Learn more at EXCELSBCBS dot
com. I'm Joelmonica. Welcome backto the Community check In. Our guest
(14:26):
is Eugene Rosenbloom, Senior Director ofTrade Relations and Enterprise drug Solutions at Excell's
Blue Cross Blue Shield. We're talkingabout a class of medications called biosimilars on
this week's community check in. Aswe just mentioned, you might have even
you might even be on one atthis point because of the popularity of that
drug that you just met, ofhume Era, and I've heard of that,
(14:48):
I've seen a lot of that.Let's recap just some of those numbers.
Currently, Excell's Blue Cross Blue Shieldis actively covering how many biosimilars that
are available on the market, allof them. So there are currently forty
three FT approved biosimilars on the market. And at Excels we have preferred biosimilars
(15:11):
in all ten of the specific drugcategories that biosimilars are available in, and
some examples include oncology, support oficology care, inflammatory disease, insulin eye
diseases. So we have preferred optionsfor biosimilars in all ten of those drug
(15:31):
categories, and I would suspect allof those categories have medications on it that
are probably substantial in cost. Isthat correct? Absolutely, all of these
medications are very expensive. Okay,And I know you mentioned insulin in there,
and that's just one. We canspend an entire show just talking about
the availability and what has happened inthat category alone that has really drawn some
(15:54):
attention to this category. Refresh usagain. It takes about how long for
a biosimilar to actually come into themarketplace after it's gone through its extensive due
diligence, when the patent comes offand they can actually start looking at the
sort of blueprint to make that biosimilar. Yeah, so it takes years.
(16:15):
So the first major hurdle is thepatent. So once the patent life is
over and manufacturers of the original biologicmight have a pen for ten or more
years, so it takes a longtime for that patent to go away and
be resolved. And so then youtake the biosimilars which need to be reverse
(16:37):
engineered, and then you have tocomplete the clinical studies so they must have
the same clinical effectiveness and safety profileas that reference drug, and so they
can be used to treat the sameconditions, and the manufacturer must also demonstrate
that its product has no clinically meaningfuldifferences. That's very important, which to
(17:00):
show that it works similarly in thebody. So you're talking about safety,
you're talking about purity, you're talkingabout potency. So even though it may
take less time overall compared to aregular biologic, it still takes time to
develop because, as I mentioned earlier, producing biologic and biosimilars, it's like
building a spaceship. It's highly complexproducts. You mentioned reverse engineering, the
(17:25):
frontiers that science is able to do, and how they're able to come up
with answers to these complex problems.I mean, you look at some medications
throughout history and some categories or classesof medication and how many decades it may
have taken to do the research.Just quickly, in your observation, is
science accelerating because of the tools thatare available to them now? And we're
(17:48):
not just talking about you know,you know, medications that currently exist and
then research that can be done basedon other people's work, But is the
pace at wheen which some of thisreverse engineering can happen. Are you seeing
it accelerating because of the tools thatare available. Oh, certainly with scientific
advancement, it's amazing that the typesof treatments available. So when you're looking
(18:12):
at different disease states, there's somany different options now available. So you
know, decades ago, when youtake something like blood pressure, there might
have been two drugs available. Nowthere's you know, over twenty drugs available
to treat blood pressure. But Ithink really the most advancement has come in
those rare diseases where previously there wasno treatment option at all, and there
(18:38):
was nothing that can be done forthese unfortunate patients. And now with advancement
and medical technology, there are drugsused to treat a lot of these rare
conditions. A lot of these aregenetic conditions that you're bored with, and
so we've got great medications now availableto help more and more patients who need
them. Who's getting in the game. Are all the players getting into the
(19:00):
biosimilar game? Yeah, so,Joe. Anytime you turn on the TV
or read a magazine, you're goingto see an ad from a drug manufacturer,
and those same large manufacturers are oftenmaking the biosimilars. So just a
few examples of some names you mighthave heard of our Fizer, am gine
saandtos Milin, and there's many morewho are making these biosimilar medications. And
(19:25):
our manufacturers stepping up to offer anykind of patient assistance. I know some
manufacturers or some medications will offer thatsay, if you need help paying for
it, we do have some availabilitythere is in this space. Our manufacturers
stepping up, Oh absolutely. Somanufacturers often offer these patient assistance programs or
(19:45):
you may call them coupid cards,and most biosimilar manufacturers have the same or
even better than compared to the otherbrand biologic manufacturer. So those will help
offset members out of poplict costs forthose types of medications. And so you
can just go on on the websiteand look for those specific drugs to find
(20:07):
those manufacturer systems programs, or ifyou need help, certainly consult with your
doctor pharmacist. Eugene Rosenbloom is Seniordirector of Trade Relations and Enterprise drug Solutions
at Excell's Blue Cross Blue Shield.We'll talk more about biosimilars where the community
check in continues for everybody who believesthe care they deserve should always be within
reach for everybody who wants to beconfident about insurance for the next phase in
(20:32):
life, for everybody who's looking forthe best ways to take care of their
employees and their families. At Excell'sBlue Cross Blue Shield, we're making care
more accessible and affordable in more waysand for more people in our community,
because when we do that, everybodybenefits. Learn more at EXCEL'SBCBS dot com.
I'm Joelmonica. Welcome back to theCommunity check in. Our guest is
(20:56):
Eugene Rosenbloom, Senior director of TradeRelations and Enterprise drug Solutions that Excel as
Blue Cross Blue Shield. We've beentalking in this community check in about biosimilars.
It is about a specific category orclass of drug. Are they only
available in the US or is thisa global availability for these drugs or are
there different types of them that areavailable in different corners of the world.
(21:18):
That's a great question. So they'reavailable globally, So Europe has had them
since two thousand and six, Canadasince two thousand and nine. So Europe
and Canada are ahead of the USin that area. And we can look
at these countries and learn from theirsuccesses instituting and sustaining a biosimilar market over
the last decade, and by learningand leveraging what other countries have done,
(21:42):
it helps prove that biosimilars are equallysafe, effective, and lower cost alternatives
to specialty biologics. Because of thefact that so much has to happen with
research and testing and data driven herein the United States. Has that put
us in a place where I don'twant to say we're behind everyone, but
(22:06):
are we just doing things here inthe United States the way we know it's
best for us to do for ourpopulation and putting the steps through biosimilars to
make sure that they're ready for market. Well, other countries also require extensive
clinical testing for biosimilar So I thinkit's just with different regulations and legislation that
(22:27):
the US is a is a littleslower to embrace these. But we're here
now and that's the important thing,and we can move forward and have these
options available for our members. Andas we get ready to wrap up our
conversation here this week, what domembers need to know about what's available and
(22:48):
how they need to have productive conversationswith their healthcare team about maybe a drug
in this category or class is goingto be right for them. Absolutely,
so biosimilars may help you save significantlyand increase access to medicines. When we're
looking at the price, some biosolersare eighty five percent less expensive than their
brand counterpart, so it's a significantdifference. So if you're in a biologic
(23:14):
medication, talk to your doctor orhealthcare professional to see if biosimilars are available
and are appropriate for you. EugeneRosenbloom is the senior director of Trade Relations
and Enterprise drug Solutions at excel AsBlue Cross, Blue Shield. Eugene in
our final two minutes of the programtoday, we've talked a lot about the
advancements in medication, how biosimilars arereducing costs, often substantially. We're talking
(23:37):
about increasing access. So they're doinga lot of good. Bottom line for
you from where you sit, whatare you looking forward to with potentially excitement
about the doors that this category ofmedication are going to be able to open
up in the near and long term. Yeah, it definitely opens up opportunit
(24:00):
comunities for members in our community wherehealthcare costs are very important to them.
So having lower priced options that workjust as well is a great benefit to
our community, and we would liketo see hopefully more advancements in this as
time progresses, opening up additional categoriesand helping reduce costs so that can be
(24:21):
again better outcomes, longer term outcomes, patients having better quality of life for
longer Eugene Rosenbloom, thank you somuch for spending time with us on this
community check in and getting us behindthe scenes of biosimilars. Thank you,
Joe, appreciate it. Thanks forjoining us on Community check in. A
presentation of excel Us Blue Cross BlueShield at iHeartRadio. Podcasts of Community check
(24:44):
In are available on the iHeartRadio appor wherever you find your favorite audio content.
For more ways to stay safe,healthy and educated, visit excel USBCBS
dot com and follow on Instagram andFacebook
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