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WHEN CHOICE ARRIVES: Competition & Consequences

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BIOSIMILAR APPROVALS

Cameron Santoro is an associate editor for The Center for Biosimilars

Videos

Here are the top 5 biosimilar articles for the week of April 7, 2025.

The Top 5 Biosimilar Articles for the Week of April 7

Articles

Biocon Biologics expands its oncology biosimilar roster after gaining FDA approval for Jobevne (bevacizumab-nwgd), the sixth biosimilar referencing Avastin (bevacizumab).

FDA Approves Biocon Biologics' Bevacizumab Biosimilar

Teva and Samsung Bioepis have launched Epysqli, a cost-saving Soliris biosimilar, offering a 30% discount and new hope for patients with rare, life-threatening hematologic conditions.

Teva and Samsung Bioepis Launch Biosimilar Epysqli 

Sarfaraz K. Niazi, PhD, is an adjunct professor of biopharmaceutical sciences at the University of Illinois and the University of Houston, and founder of biosimilars companies Karyo Biologics and Adello Biologics. He also founded the biosimilar advisory company PharmSci.

Affirming that analytical characterization is often sufficient for biosimilar approval, minimizing unnecessary clinical testing, and enhancing FDA-led education to counter stakeholder misconceptions are key recommendations put forth in this opinion piece by Sarfaraz K. Niazi, PhD.

BioRationality: Commemorating the 15th Anniversary of the BPCIA

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Business & Practice

Patent thickets, patent litigation, patent dances—all of these legal terms have plagued the biosimilar space, causing many biosimilar products to launch well after the originator's market exclusivity was supposed to expire. A perfect example of this is the Stelara (ustekinumab) space, where patent litigation settlements have led to delayed market access for ustekinumab biosimilars from late 2023 to early 2025. Additionally, congressional leaders have had to investigate AbbVie for potentially abusing the patent system to stall biosimilar competition for Humira (adalimumab).

But why does the system work like this? What can be done to improve it? What actions can be taken to ensure the patent system doesn't hinder competition and innovation?

On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.

To read more of Ha Kung's thoughts on the US patent system and its role in the biosimilar landscape, 

To learn more about Congress' role in addressing AbbVie's alleged anticompetitive practices regarding adalimumab products, 

To learn more about the suit filed by CareFirst BlueCross BlueShield regarding ustekinumab biosimilar delays, 

To learn more about the settlements that have resulted in the market delay of ustekinumab biosimilars, 

To learn more about lawsuits involving AbbVie that led to the delayed market entrance of adalimumab biosimilars, 

To learn more about what types of patents are at most to blame for biosimilar market delays, 

On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.

Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars

On June 17, 2021, the Supreme Court ruled that opponents to the Affordable Care Act (ACA) did not have standing to challenge the law based on the constitutionality of the individual mandate, which provides for a penalty (currently $0) for those who do not obtain health care coverage. Had the Supreme Court struck down the entire ACA, it would have brought an end to the approvals pathway for biosimilars that is contained within the ACA under the Biologics Price Competition and Innovation Act.

The Center for Biosimilars® spoke with Stacie Ropka, PhD, a patent litigator and partner at Axinn, Veltrop & Harkrider of New York, New York, about the significance of this ruling and the conclusions that can be drawn from it.

Ropka discusses the narrow terms upon which the Supreme Court rejected the petition to strike down the ACA. The court ruled on the issue of standing—whether the plaintiffs had suffered harm because of the law—which they had not, rather than the merits of the case. The plaintiffs contended the individual mandate (Section 5000A) is an integral part of the ACA and therefore, if unconstitutional, should be struck down along with the entire ACA. The court never got to that argument.

Ropka explains what course of action may be available at this point for the plaintiffs, a collection of GOP-governed states led by Texas. She discusses the dissenting opinion on the high court and weighs the significance of the ruling for Congress, which created the ACA and now has an opportunity to make it more watertight, or not.

For background reading on the ACA case, read about the June 2021 ruling 

, and for background on the withdrawal of the Department of Justice from the plaintiffs’ side of the suit, click 

The Supreme Court’s ruling in the Affordable Care Act (ACA) case appears to have saved the biosimilars approval pathway, but do the plaintiffs have other avenues by which to bring another challenge? 

Not So Different: Axinn Patent Litigator Discusses Implications of ACA Ruling

Before the battle for market share gets started, the courtroom is the OK Corral for biosimilar developers and reference product manufacturers, who duke it out over patents to determine how soon biosimilars can enter the marketplace. We spoke with Alexandra Valenti, JD, and Rob Cerwinski, JD, Goodwin partners and senior editors of the updated 

Guide to Biosimilars Litigation and Regulation in the US

To learn more about Valenti and Cerwinski's updated guide, click 

To learn more about adalimumab patent disputes, click 

To learn more about the future state for the adalimumab market, click 

Key 2020-2021 updates to the Guide to Biosimilars litigation and Regulation in the US encompass antitrust litigation, preliminary injunctions, and a slowdown in litigation.

Not So Different: Goodwin Attorneys Discuss Updates to Biosimilars Litigation Guide

In the past decade of experience with the the Biologics Price Competition and Innovation Act, a number of questions about the biosimilar pathway have been resolved through litigation. This week on the podcast, we're speaking with attorneys Robert Cerwinski, JD, and Alexandra Valenti, JD, both of whom are partners at Goodwin, about experience with litigation, the road ahead for biosimilars, and Goodwin's recently published guide to biosimilars litigation. 

In the past decade of experience with the Biologics Price Competition and Innovation Act, a number of questions about the biosimilar pathway have been resolved through litigation. This week on the podcast, we're speaking with attorneys Robert Cerwinski, JD, and Alexandra Valenti, JD, both of whom are partners at Goodwin, about experience with litigation, the road ahead for biosimilars, and Goodwin's recently published guide to biosimilar litigation. 

"Not So Different": Goodwin Attorneys Give a Look at Biosimilar Litigation

Those who follow the biosimilars space closely are aware that, in the context of the US market, legal concerns regarding biosimilars can be just as regulatory ones in informing how drug makers do business. 

One recent case that impacts on upon the biosimilars market was recently heard before the before the United States Supreme Court, and the outcome of the case will potentially impact drug makers seek patent protection for various aspects of their products.

In order to take a deeper dive into the case, and hear an expert perspective on its far-reaching impacts, this week, we’re speaking with Ha Kung Wong, JD, a partner at 

 and an advisory board member for The Center for Biosimilars

Those who follow the biosimilars space closely are aware that, in the context of the US market, legal concerns regarding biosimilars can be just as regulatory ones in informing how drug makers do business. One recent case that impacts on upon the biosimilars market was recently heard before the before the United States Supreme Court, and the outcome of the case will potentially impact drug makers seek patent protection for various aspects of their products.

"Not So Different:" The Supreme Court and US Biosimilars

The denosumab biosimilar market is poised for disruption with 3 FDA-approved biosimilars, at least 5 awaiting approval, and launches anticipated to start in May 2025, while ongoing patent litigation continues to shape the competitive landscape.

Biosimilar Cases to Watch: Prolia/Xgeva and Denosumab Competitors

Reforming patent litigation to mirror successful outcomes across Europe could significantly accelerate US biosimilar market entry.

Earlier Patent Litigation Could Accelerate US Biosimilar Market Entry

The top legal stories in biosimilars from 2024 emphasize the ongoing struggle between ensuring timely patient access and addressing challenges like litigation, regulatory hurdles, and patent disputes that shape the competitive landscape of affordable biologics.

Breaking Down Biosimilar Barriers: The Patent System

Regeneron appeals legal decision after judge refuses to block an aflibercept biosimilar; Prime Therapeutics, a pharmacy benefit manager (PBM), becomes the latest to offer biosimilars referencing Humira (adalimumab) at a low cost; the FDA and European Medicines Agency accept a denosumab biosimilar candidate for review.

Eye on Pharma: Aflibercept Legal Drama; PBM, Humira Biosimilars; Denosumab Regulatory Review

global biosimilars week webinar

 was hosted by The Center for Biosimilars

 in partnership with the International Generics and Biosimilars Association.

Global Biosimilars Week (GBW) 2024 is an annual campaign designed to raise global awareness about biosimilar medicines and their role in improving patient care and access to affordable treatment options.

This year’s theme, "Advancing Access to Biosimilars," focuses on the progress made over the past two decades surrounding approval, market acceptance and adoption of biosimilars—as well as the challenges that remain in expanding access worldwide. With an effort to highlight the importance of collaboration among health care professionals, patients, stakeholders, and policymakers, the webinar will focus on 

 to advance access to biosimilars and will feature expert discussions on the key barriers to biosimilar uptake in different regions and explore strategies to overcoming these obstacles.



Current global trends in streamlining biosimilar regulatory requirements to foster efficient adoption and market growth.

Strategies to address challenges and improve biosimilar access.

The role of biosimilars in promoting health care sustainability and better patient outcomes.

, assistant managing editor of The Center for Biosimilars (host)

, senior vice president of sciences and regulatory affairs, Association for Accessible Medicines (moderator)

, PhD, Executive Director for Products Evaluation and Standards Setting, Saudi Food and Drug Authority

, PhD, scientist, technical standards and specification unit group lead, norms and standards for biologicals, Health Product Policy and Standards/Medicines and Health Products/World Health Organization 

enior quality specialist, European Medicines Agency

, director, Office of Therapeutic Biologics and Biosimilars Office of New Drugs, Center for Drug Evaluation and Research, FDA

This webinar celebrating Global Biosimilars Week was hosted by The Center for Biosimilars® in partnership with the International Generics and Biosimilars Association.

Webinar: Streamlining the Regulatory Process to Advance Access to Biosimilars

Ha Kung Wong, JD 1

, Ha Kung Wong, JD, is a lawyer practicing general intellectual property law, emphasizing patent and trade secret litigations. Wong negotiates for mergers, acquisitions, vendor agreements, and collaborations in pharmaceuticals, biologics, chemistry, medical devices, digital health, and artificial intelligence. He has represented Alkermes, Allergan, Alnylam, Materia, Shionogi, Stemline, UCB, and Bill & Melinda Gates Foundation and Gates MRI as clients.

This interview for the Center for Biosimilars

 focuses on Wong's perspective of the patent legal system, the importance of this process, and how it affects biosimilar development.

Can you explain the patent legal system biosimilars are required to undergo and why this process is important to their development?

Sure, so for biosimilars, there's the BPCIA or the Biologics Price Competition and Innovation Act of 2009, which is actually an optional framework of information exchanges between biosimilars and the reference product sponsor, or what we call the RPS, prior to filing an infringement lawsuit.

The BPCIA allows for 2 phases of litigation. One, following the biosimilars aBLA [abbreviated biologics license application] submission and the second phase triggered by the biosimilars notice of commercial marketing. Now, the idea is that the most important patents can be dealt with while the biosimilar application is under FDA review. That gives the possibility of resolving the lawsuit after only litigating a small subset of patents, instead of the RPS' entire portfolio. That can be quite large and sometimes in the hundreds.

So, to start this first phase exchange of materials, which is often referred to as the patent dance, the biosimilar notifies the RPS that the FDA has accepted its biosimilar application within 20 days of that acceptance and provides the RPS with its aBLA and "other manufacturing information".

That starts off this kind of exchange of information regarding the patents that might be infringed by the biosimilar and which they think might be likely to be licensed whether the biosimilar feels like there is an infringement, validity, or enforceability problem or not. Ultimately, what happens in the first round of litigation is that you narrow the number of patents that you actually litigate right away. If the parties can't agree, the BPCIA gives a provision for determining the list of patents that can be litigated in the first phase and the remainder gets litigated in the second phase.

For most BPCIA litigations that most parties have participated in at least some part of the dance and as I mentioned before, it was after the statute came out it was decided by the courts that this was optional.

A lot of people said, "Well, why would anybody go through this?" It turns out, it helps both sides, right? The biosimilar gets that chance to narrow it down to the patents that are most important so they're not expending an enormous amount of resources litigating hundreds of patents, and the RPS gets a chance to really zone in on the patents that are most important to them and try to protect them first, then try to seek licenses on those that can be some sort of settlement. So 24 of the litigations that have occurred, have completed this entire patent dance, 19 participated in some portion of it and didn't finish, but only 9 didn't participate.

You can see that even though it's optional, a lot of parties find some benefit to going through this process. Now, the interesting thing about it is that when it came out, I thought this is the most half-baked process ever.

That's still true, but it's better than nothing is what I think is happening. Most of the BPCIA litigations are actually ending in settlements. Thirty-one of 46, or 67%, of terminated BPCIA litigations ended in settlement or stipulated voluntary dismissals.

Very few cases have gotten the verdict, which is actually part of what we want. I think this statistic that I'm raising is demonstrating that the primary benefit of the BPCIA process is being met. That was to resolve any patent related disputes early, prior to impact on the market, thus allowing both parties to direct resources appropriately to their respective products and avoid the need to address potential damages.

In many ways, this is similar to what the Hatch-Waxman process was meant to address for small molecules. So far, it appears to be working for biologics and biosimilars, and really helping in development on both sides.

In an interview with Ha Kung Wong, JD, he addresses the patent legal system biosimilars are required to undergo and how this helps resolve patent disputes early in the development process. 

Navigating the Biosimilar Patent Landscape With Ha Kung Wong

Jeffrey Casberg, vice president of pharmacy at IPD Analytics, discusses the Alvotech/AbbVie 

 for an adalimumab biosimilar referencing Humira  and whether it will impact future patent lawsuits at the Academy of Managed Care Pharmacy (AMCP) annual meeting.

What do you think that the recent settlement between Alvotech and AbbVie could have for future patent lawsuits, especially for those that may involve the ITC [International Trade Commission]?

First, what is the settlement agreement? So, [several] weeks ago, we had a settlement agreement between Alvotech and and AbbVie. Alvotech has a [adalimumab] biosimilar product they're looking to bring to market. AbbVie's the [reference] manufacturer and they'd prefer not to have more competition. But what happened is that both sides had their arguments, but both sides weren't completely sure they would win. And if they did have to go to litigation, the litigation could go on forever, and it could get very expensive.

So, for various reasons, both sides come to a meeting and they say, "Okay, we want this," and they negotiate. They come to a settlement agreement to say, "Okay, we agree that you can launch the biosimilar product, or generic in some cases, on this date." So, that occurred. And the agreement said that alphatech can launch AVT02, the new formulation [referencing] Humira in July 2023.

That changed everything as well, because there was a couple other companies out there, Celltrion Healthcare and Samsung Bioepis/Organon have products. And we hadn't heard much about them. And because we hadn't heard a lot about them, we had figured they probably also had settlement agreements, but weren't saying. So, the information was not publicly available. Now, IPD [Analytics] is assuming that if Alvotech has a settlement agreement with this date, it's likely that Celltrion and Samsung Bioepis/Organon have similar dates.

The settlement agreement is significant because payers can now negotiate with biosimilar manufacturers for both access to original formulation and new formulation products and not have to worry about the conversion effort that would have taken place if only the original formulation came out. So, it changed the game. It's going to make it a lot smoother for payers and a lot better for consumers of the product. It likely will increase adoption of these biosimilar. I think previous to a few weeks ago, adoption would have been modest year 1 [after launch]. I think it will be significantly more than modest now, especially in the second half of the year.

In 2023, we're going to get also interchangeable products. So, for the original formulation we're going to get Cyltezo by Boehringer Ingelheim and Abrilada by Pfizer both launching around July 1 with interchangeability. And then also around July 1, we'll may get the Alvotech/Teva Pharmaceuticals product AVT02 launching with interchangeability. How important is that interchangeability? I guess that's a whole nother session to talk about. So, we'll take that as it comes as [we see] additional launches in 2024 and later.

Jeffrey Casberg, vice president of pharmacy at IPD Analytics, discusses the Alvotech/AbbVie settlement for an adalimumab biosimilar and whether it will impact future patent lawsuits.

Jeffrey Casberg Discusses the Alvotech, AbbVie Settlement Over an Adalimumab Biosimilar

CfB: I'm Tony Hagen with The Center for Biosimilars. Today, we're speaking with Sean McGowan. He's the senior director of Biosimilars for AmerisourceBergen. Welcome, Sean.

CfB: Sean, can you comment about biosimilar approvals in 2021? It was a pretty interesting year, I think, even though we had just a few.

McGowan: Yeah, it was it was quite a year of firsts for biosimilars in 2021. And in starting with the biggest approval and launch onto the market with the Semglee [insulin glargine] product from Mylan/Viatris. In July of 2021, the FDA approved the first ever interchangeable biosimilar product in Semglee, an insulin product indicated for treatment for type 1 and type 2 diabetes. That product launched in November with actually 2 versions of branded and an unbranded version. So, Semglee's entrance into the retail pharmacy, including mail order pharmacy, space makes it the first biosimilar to be covered under patients’ pharmacy benefit or Part D plans. So, kind of a first of its kind.

And the interesting thing about the Semglee launch is that it's got the potential to positively impact millions of more patients with its availability at the pharmacy counter. And this is definitely going to be a preview of what's to come with the future of Part D biosimilar launches. Not to mention that Semglee has been recently adopted on to a couple of national PBM [pharmacy benefit manager] formularies, including Express Scripts and Prime Therapeutics.

As we look into other therapeutic areas in 2021, we also saw the first biosimilar approval in the retina-ophthalmology space with Biogen's Byooviz, which references Lucentis [originator ranibizumab]. In October, we saw the FDA approved Cyltezo, making it the first interchangeable biosimilar product referencing Humira [originator adalimumab] and only the second interchangeable product ever to be approved by the FDA. And just to clarify, Cyltezo already had FDA approval. It was that interchangeable designation that received approval back in October.

Then in late December, right before the end of the year, the FDA approved 2 other biosimilars: an insulin glargine product from Lilly and then Yusimry, a biosimilar referencing Humira from Coherus [Biosciences]. So, all of these approvals and entrances in 2021 indicate to me that the FDA is getting back on track to reviewing and approving these products so patients can access these treatments. Also, it's an indication that the market continues to expand.

CfB: Just a footnote to that introduction. The Semglee launch was both a branded and unbranded. Can you shed any light on why that strategy was chosen by Biocon?

McGowan: Yeah, so Mylan and Viatris are the commercial partners and US Biocon is the manufacturing partner and from what I can see and what's been published publicly is that there's actually a non-biosimilar version of Semglee already on the market that had launched back in [the] summer of 2020. And that product came out on the market with a heavily discounted WAC [wholesale acquisition cost] price and looked to be launched to compete more in the Medicare Part D and Medicaid space or those cash paying patients. And then as the biosimilar products were being approved, Mylan/Viatris was looking to compete both in the commercial space as well as that Medicare/Medicaid space. And so, they've kind of launched the same product under 2 different names, 1 branded and 1 un-branded to fit specifically into some specific payer markets. And so, we're less than a quarter into the launch of this product and time will tell on how that strategy actually plays out.

CfB: Thanks. So, at the GRxBiosims meeting, which is a fairly informative conference, there were several FDA representatives speaking and they seemed a lot more focused on biosimilars than they had been in the past. Coming out of the pandemic, or at least, maybe partway through the pandemic, what does this signify, do you think?

McGowan: Yeah, it was great to see the quality and safety of generic and biosimilar medicines was a top priority for our industry and a key theme of the meeting. So, I'd say this progress is motivating and moving in the right direction. The FDA has also promised to provide more clarity on the handling of the interchangeable designation, which I think everyone is really interested to gain some additional clarity and insight into that designation, as we see more and more products receive that designation in the future. It's also encouraging that the pharmacy benefit managers have been moving interchangeable biosimilars onto their preferred formularies like they've done with Semglee and that pharmacists in the retail space now get a chance to experience a biosimilar product. But overall, there's still a lot of basic education required about biosimilars to generate more confidence in their use across all stakeholders in the supply chain.

CfB: So, you have a terrific pipeline report on biosimilars, which is updated regularly. Can you tell us what we can look forward to in biosimilars in the insulin market in 2022?

McGowan: Yeah, sure. So, with 2 approved insulin glargine products, we'll see that market become more and more competitive once Lilly announces the launch timing of their insulin glargine that just recently received approval. We're seeing a product being developed by Sandoz that's currently in phase 3 trials. Last week, we saw an announcement that Biocon's application for its insulin aspart received a CRL [complete response letter] from the FDA but Biocon seemed to be confident that they're going to be able to provide the additional data that's required there. So, we'll see some additional markets either open up or expand in the near future.

We also have another insulin glargine from Lanett that's in the preclinical clinical trial stage. And so, we're expecting, at least based on what they've disclosed, that their clinical trials will start Q1 or Q2 in 2022. And then they're looking for FDA approval in 2023 and a potential launch in 2024.

Finally, there are about 5 rapid-acting insulin biosimilars currently in the pipeline for manufacturers including Biocon, Viatris, Sandoz, and Sanofi. And they're all in different clinical trial stages at this time, from preclinical to phase 3. So, I anticipate more of these insulin products to continue to be developed and hopefully approved and launched onto the US market in the coming years.

CfB: So, this year is shaping up to be a positioning race for adalimumab biosimilar market entry. They don't actually arrive until 2023 but what can you say about the positioning that's going on and how companies are looking to stand out in this market?

McGowan: Yeah, you're absolutely right. 2023 is going to be the year of the Humira biosimilars. And I think we're all anxiously waiting to see how this plays out. And it is going to be 1) very interesting and 2) I think a bit complicated with the number of manufacturers that are already set to launch products in 2023 [n = 7]. And then, how are they going to compete against the existing versions of Humira? So, as far as timing is concerned, Amgen will be first out of the gate with their product launching at the end of January 2023. And they're going to have about a 5-month head start over the next tranche of manufacturers that'll bring their Humira biosimilars to market. So, the next group will have Organon, [Boehringer Ingelheim], and Coherus launch their products in that middle summer timeframe, kind of end of June and early July. Then, we're going to see Viatris, Sandoz, and Pfizer launch their products between August and November in 2023. And then, we also know that Teva, in partnership with Alvotech in the development of that Humira biosimilar, is waiting for FDA approval, but launch timing is really unknown at this point.

CfB: As an aside for the Amgen now, Amgevita [adalimumab biosimilar] will have that 5-month head start. What do you think will be the lasting impact of that advantage?

McGowan: Right now, Amgen definitely is positioned to have the advantage from that timing standpoint and that head start over everybody else. Just a couple of things to take into consideration, you're absolutely right that 2023 is going to be an exciting year, but keep in mind these manufacturers are absolutely focused not only on 2023 but the several years to come after that. And so, 2023 is definitely going to be a year where the staging has taken place. Yeah, there's going to be a bit of an advantage for Amgen, and they're going to have a lot of critical decisions to make around pricing, PBM coverage, support services, patient and physician education, which is all going to have an impact on everybody else that comes after Amgen. So, I think a lot of things are going to play out, but we can't discount the fact that in the years 2024, 2025, and beyond are going to be years where these products are going to be competing. But 2023 is most certainly going to be probably the most exciting, just given the timing and the number of products that are going to come onto the market.

CfB: And 1 more question on the adalimumab pricing. What could be the effects on pricing of having so many competitors arrive on the market at the same time? Do you think that there will be a sudden drop, or do you think that given the settlements that they made with AbbVie [reference adalimumab manufacturer] that that is not going to occur?

McGowan: Yeah, that remains to be seen. I think the pricing piece is going to be interesting, just because they're going to be so many products out there and then you have this long history of AbbVie's pricing on this product. But I think a lot of the activity is going to be driven by the PBMs in which products they decide to adopt, put on their formularies, and switch patients over to. So, it's really going to be incumbent upon the manufacturers to be negotiating those deals with the with the PBMs and then which products are being adopted and which products are left off of formularies. So, at the end of the day, given that this is that pharmacy benefit space, I think the PBMs are going to play a very critical and influential role in the launch of these products.

CfB: Okay, so, etanercept has been a bit of a disappointment in terms of bringing biosimilars to market. The 2 contenders have not succeeded in breaking through the patent barriers on Enbrel [originator etanercept]. So, is there a possibility that other etanercept biosimilar makers will step forward?

McGowan: Yeah, this is certainly disappointing news for the biosimilar market, and it's been an ongoing legal battle across the last several years, especially with 2 FDA approved products out there. But the litigation rulings at this point seem to be pretty definitive. I don't foresee any manufacturers continuing to pick up the torch and continue the legal battle here, which, again, is unfortunate and it doesn't seem like we'll see an Enbrel biosimilar on the market in the US for the next several years.

CfB: In ophthalmology, ranibizumab has taken some interesting turns. Susvimo is a biobetter, some might say, and has an implant reservoir vs an injectable, which could offer great convenience to patients. Could this be a disruptor in the ranibizumab market and how could it affect biosimilar competition?

McGowan: Yeah, it’s a new market and molecule for the biosimilar markets, which is really exciting. So, it's going to be a very interesting market to watch evolve. Not only have we seen this implantable device launch onto the market, we also know that Roche/Genentech is developing their faricimab molecule, which will have retina-ophthalmology indications. So, we'll have to see how successful they will be at launching that product, which will have patents and exclusivities if and when it's approved, and then how successful they'll be in converting patients over to that product. We also have another organization and company with Outlook Therapeutics actually developing a bevacizumab product specifically for the retina-ophthalmology indications. So, that's going to be a little bit of a nuanced wrinkle and addition into an already complex and competitive market.

But on the biosimilar front, there's currently only 1 approved product from Biogen with Byooviz. And we're anticipating at least 3 other biosimilars referencing Lucentis to come onto the market in the next 2 to 3 years. So, Biogen is most certainly going to be the first product on the market in this space and what's been announced is a mid-2022 launch for that product. But it's going to be very interesting to see how the practitioners and the practices get educated on biosimilars, since they most likely have not utilized a biosimilar in the past, and how to build those into their care plans and adopt these products. Given the complexity and how heavily competitive this market is, given the innovator company's position, a new branded product coming to market, and then several biosimilars, it's going to be another very interesting market to watch evolve.

CfB: Yeah, affordability is a tremendous issue in ophthalmology. So, what else might move the needle in the biosimilar pipeline events in 2022?

McGowan: Looking ahead to calendar year 2022, I think there are a few opportunities and challenges to look for. So, going back to Semglee's launch and the availability of 2 versions, a branded and unbranded, we'll be watching closely as to how these products compete in the commercial market vs the Medicare/Medicaid or Part D plans. So, which version of the product is going to get adopted and how quickly can it grow and into what levels? And then what learnings can manufacturers glean from the strategy that Viatris has taken, and can they take those learnings and apply them to other biosimilar markets, and I think Humira is 1 specifically that jumps right to the front of my mind. So, can this type of strategy be replicated in other markets? In staying on the topic of Humira, the approval and the launch of Semglee will most certainly act as kind of a dress rehearsal for bigger biosimilar market entrance expected in the Part D space in 2023. So, having an interchangeable product and having a Part D product, a pharmacy benefit product, is most certainly going to provide a lot of learnings and education around how the pharmacists' handle these products, how the pharmacy benefit managers handle these products, how they're positioned on the formularies, and how that interchangeable designation is treated at the pharmacy counter.

And then there's some excitement in the medical benefits of the Part B space with the forthcoming launch of the first biosimilar in the retina-ophthalmology space in Byooviz, which references Lucentis and we've talked about just a minute ago. Again, that launch is expected to happen mid-year in 2022. 2022 is also going to be the year where everyone is preparing for the watershed moment of the 7 plus biosimilars referencing Humira coming onto the market starting in 2023. And with the 7 plus Humira biosimilars entering the retail and specialty pharmacy space, a whole new customer group and market will be introduced to biosimilars. So, again, kind of going back to my point earlier around the education piece and how this continues to be a critical element to improve the adoption of biosimilars, the aperture expands exponentially as these retail pharmacy and specialty pharmacy products come onto the market.

And then just some considerations for the biosimilar market moving forward. We'll continue to watch how manufacturers of innovative products respond to biosimilars. A great example, Janssen towards the end of 2021 launched an unbranded version of Remicade [originator infliximab] similar to how Semglee was launched both branded and unbranded. Now, we've got an innovator product in the Part B space with a branded and unbranded [version]. We'll most certainly make note of whether or not this strategy is successful and then whether or not other innovator companies adopt a similar strategy. We're also expecting to see a new set of manufacturers launch biosimilar products into existing markets, as well as new biosimilar markets like Biogen with their Lucentis biosimilar. Finally, existing biosimilar markets will become more competitive with new entrants. All of this is really great in my opinion because these manufacturers continue to see an opportunity for biosimilars, and patients will benefit from increased competition that helps improve access and affordability.

CfB: Terrific, Sean, thanks. Finally, the Build Back Better Act has been through a lot of drafts, and we don't know whether it's going to see the light of day. What are your thoughts on how this might affect biosimilars in the final version, if there is one?

McGowan: Yeah, that's a great question and I know a lot of focus on the Build Back Better Act was paid in the November timeframe before the legislators shut it down for the end of the year. We're going to be following this very closely to see what policies actually make it into the bill, in whatever way shape or form that happens. I think we all want to see policies that continue to support a market that allows for biosimilar competition, encourages manufacturers to invest in the space, and helps to bring down drug prices and the overall cost of care. Despite all the challenges and hurdles the biosimilar market has had to overcome across the last several years, biosimilars have most certainly delivered on their promise to expand access, drive down costs, and deliver on savings.

CfB: Thanks very much, Sean. It's great talking with you again about biosimilars at The Center for Biosimilars.

Sean McGowan, senior director of Biosimilars for AmerisourceBergen, forecasts potential biosimilar approvals and launches in 2022 as well as offers insights into how emerging biosimilars will impact the market and pricing in the coming years during an interview.

AmerisourceBergen Rep Previews the Year Ahead for Biosimilars: What’s Coming Down the Pipeline in 2022?

Imagine that all 50 states in the United States had different biosimilars policies affecting pricing, usage, availability, promotion, and payer reimbursement. It’s something like that in the European Union, although there are overlapping trends from member member state to member state. 

In this first part of a 2-part series, Tony Hagen, senior editor for The Center for Biosimilars®, interviews Adrian van den Hoven, director general for Medicines for Europe, and Diogo Piedade, market access manager for Medicines for Europe, about findings from the group’s recent European survey of biosimilar markets: Market Review—Biosimilar Medicine Markets.

The report elucidates policy variation and biosimilar penetration across EU markets. The biosimilar dispersal is not uniform, van den Hoven and Piedade explain. In the case of insulin, where competition is strong, biosimilar versions may be left out of the game.

In the United States, biologics producers have freedom to set their own prices, and the amount and type of competition may influence the discounts on biologics that are seen; but in the European Union price regulation is more often the norm, and competition between producers adds another level of discounting that results in the true cost, market by market, van den Hoven and Piedade explain.

The discussion also touches on the practice of reference pricing. In the European Union, drug reimbursement is sometimes pegged to a common value that is established through competition among producers. This is known as reference pricing.

However, this practice can lead to unsustainably low prices, van den Hoven and Piedade explain. They provide a few different examples of how producers have been affected, along with recommendations for improvement.

They also provide insight on the pros and cons of the length of the contracts, or tenders, producers receive to supply their biologics to EU markets. Longer tenders provide companies with a stable revenue flow, but these may outlast other producers’ staying power, or willingness to return for the next tender opening and bid to supply their own products.

Adrian van den Hoven, director general for Medicines for Europe, and Diogo Piedade, market access manager for Medicines for Europe, discuss the group’s recent EU report: Market Review—Biosimilar Medicine Markets. 

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