John Bujnoski is Managing Director of Pangea Advisory and Consulting, LLC, a strategic marketing consulting firm focused on the specialty biopharmaceutical and biosimilar market segments. John has extensive global biopharmaceutical industry expertise including extensive knowledge and understanding of the global market environment including pricing, market access, and reimbursement systems.

John Bujnoski

Safaraz Niazi, PhD, is an adjunct professor of biopharmaceutical Sciences at the College of Pharmacy at the University of Illinois at Chicago and a patent law practitioner. Additionally, he is the founder and executive chariman at Pharmaceutical Scientist, Inc, the executive chairman of Karyo Biologics, and the founder of Adello Biologics, which was acquired by Kashiv Biosciences in 2019. Niazi also serves on the advisory board for The Center for Biosimilars®.

Sarfarzaz K. Niazi

George C. Yu, JD, is a partner in the Intellectual Property group of Schiff Hardin LLP. He is an experienced patent attorney who focuses his practice focuses on patent infringement litigation and counseling and has worked in private practice and in-house positions. George has litigated patents relating to recombinant proteins, monoclonal antibodies, microarray technology, and small molecule therapeutics. George has advised companies developing novel biologics as well as biosimilars on patent strategy.

George C. Yu, JD

Coronavirus disease 2019 (COVID-19) altered the workflow in all areas of the health care and life sciences industries. The FDA was not exempt from pandemic-induced upheaval. Meetings of advisory committees, which provide the FDA with expert advice on scientific, technical, and policy matters, were often postponed, and although drugs were still reviewed and approved, significant delays occurred.

From the start of the United States’ response to the COVID-19 pandemic in March 2020 until late summer, 2 biosimilars were 

: Hulio (adalimumab) and Nyvepria (pegfilgrastim). This represented not only an improvement in patient access and affordability of life-changing medications, but also a slowdown in biosimilar approvals.

In previous years, biosimilar approvals had steadily increased. As shown in the figure, the projected trend suggested approximately 12 biosimilar approvals for 2020 and 14 for 2021.

The trend line for biosimilar approvals suggested 2020 would be another strong year for the emergence of these lower-cost therapies; however, just 2 had been approved by the midyear point.

Although other factors came into play, such as patent expirations and product development, it appeared unlikely that the total of 12 biosimilar approvals would be achieved in the final quarter of 2020, and there was even potential for this slower pace to extend into 2021.

There were other reasons why patient access did not improve as expected. Typically, once manufacturers receive biosimilar approval, many face 

 that delay products from reaching the market promptly. These court cases often are purposely filed to interfere with market access to a new product. In some cases, “

” agreements postpone market entry of a biosimilar for many 

The COVID-19 crisis extended these delays because court systems temporarily closed to prevent spread of the virus and reopenings were late or occurred only in stages. Well into 2020, virus hot spots 

 to stall judiciary system operations, adding to the time needed to achieve market access for these new therapy options.

In addition to regulatory and judicial barriers, the overwhelming workflow within health systems also played a role in limiting access to new therapies. When health care facilities are in crisis mode, many components of the reimbursement and education processes, each of which is vital for biosimilar uptake, are hindered. 

Pharmacy and therapeutics (P&T) committees are necessary for ensuring new therapies will be included in the health care facility formulary. From the start of COVID-19, P&T meetings were often conducted virtually or 

 on evaluating emerging therapies for COVID-19 treatment, leaving little time for consideration of other formulary additions. With so much focus on COVID-19, little time was allocated to much else.

Within hospitals, the same was true regarding in-service education for physicians. With a need to educate physicians on current protocol, diagnostics, and treatment surrounding COVID-19, there was not much time left to educate on biosimilar therapies and novel agents.

“Lunch and learn” programs were likely on hiatus during the pandemic due to social distancing requirements, understaffing, and a strain on funding. Gathering professionals into a conference room could not be prioritized over keeping everyone safe.

Typically, many facilities partner with manufacturers to supply marketing materials and food to lunch and learns, and a clinical staff member presents on the topic at hand. As manufacturer field teams were grounded, less information reached the health care providers. Most nonessential visits were prohibited to prevent unnecessary risk of virus spread. These grounded professionals included sales representatives who provide information about new products, field reimbursement specialists who assist in getting products approved by the health plans, and medical science liaisons who can discuss new products on a higher level. These professionals were not as physically active as the pandemic unfolded and virtual methods of interaction were implemented.

If new therapies, including biosimilars, were not approved by the FDA, litigated promptly in the courts, cleared for formulary placement, or explained to physicians, it is unlikely patients were learning much about them. Especially when it comes to biosimilars, patients need to be aware of their potential options and the associated benefit of cost savings. With COVID-19, the nation entered a time of financial instability and loss of health care coverage, and these new therapy options became even more important for safe and affordable health care.

Coronavirus disease 2019 altered the workflow in all areas of the health care and life sciences industries, and the FDA was not exempt from pandemic-induced upheaval.

The Pandemic's Multilevel Effect on Patient Access

Amanda DeMarzo, PharmD, MBA, PACS, is the associate director of Patient Access with the National Board of Prior Authorization Specialists, an affiliate of the Accreditation Council for Medical Affairs, based in Oradell, New Jersey. She focuses on how to improve the current health care system as a whole through improved training, widespread certification, and advanced technology for better patient outcomes. She developed a passion for patient-centered care and shared decision making during patient-facing roles over the last 8 years.

Amanda DeMarzo, PharmD, MBA, PACS

Christina Mattia

Gregory Schimizzi, MD, is a co-convener of the Biologics Prescribers Collaborative (BPC) and the cofounder of Carolina Arthritis Associates, PA, in Wilmington, NC.  He has been a licensed and board-certified rheumatologist in private practice for 30 years. He co-founded, and previously served as president, of the Coalition for State Rheumatology Organizations (CSRO). He has also previously served as president, and a member of the executive board, at the North Carolina Rheumatology Association. Dr Schimizzi completed his undergraduate and medical school studies at Wayne State University in Detroit and completed his fellowship training at the University of California at Irvine.

Gregory Schimizzi, MD

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?

Tony Hagen is senior managing editor for The Center for Biosimilars

Tony Hagen

Entering 2020, we have the opportunity to take a moment, look back, and reflect on the lessons learned of the previous decade with regard to biosimilars. The road to a successful biosimilars market has been anything but straightforward. With complications including a slow rate of approval, extended delays in product launches due to patent litigation, or the small and incremental degree of economic impact, it’s easy to become frustrated and question whether or not biosimilars represent an economically prudent investment in the new decade. 

While I would not argue with anyone that we should expect more from the biosimilars opportunity, simply throwing the baby out with the bathwater at this point would be a monumental mistake that fails to see the growing opportunity the space provides us. Essentially, these hurdles are not as insurmountable as they appear and can be managed if we focus our approach at the appropriate obstacles and recognize the benefits to continued biosimilar development beyond simply the primary goal of lowering the price of biologic drugs. 

The Elephant in the Room: What is a Fair Price?

While the question of pricing is critically important, we must also acknowledge the other structural and economic realities of drug prices. One prominently articulated alternative to biosimilars is the implementation of pricing regulation for biologics after they reach the end of their exclusivity period. This approach would attempt to establish a “fair price” at which an originator biologic will be sold that is intended to include all of the expenses associated with biologic development and the ongoing supply of that product. However, there are several issues with this concept that should be addressed:

Given the current political landscape, it appears rather remote that agreement on a price setting process for biologics or any other pharmaceuticals could be established within the near future.

The creation of this “fair price” would require a degree of transparency from the pharmaceutical industry far beyond anything that presently exists. Currently, there are little if any details concerning the true cost of drug development, high quality manufacturing, and consistent supply. 

The most challenging aspect of this endeavor would be establishing an agreed upon definition of a “fair price.” Given the number of stakeholders involved in and impacted by the pricing of pharmaceuticals, it appears highly unlikely that these participants would agree to a threshold for profit generation.

Realigning our Understanding of Biologics, Generics, and the Concept of Cost

Much of the recent frustration with biosimilars stems from our previous experience with generics. Over the last 35 years, generics have demonstrated that competition can drive dramatic savings with the value being recognized almost immediately. The simplicity of the molecules and the well-established mechanism of declaring products interchangeable, creates a clear pathway for competition. However, the US healthcare market is now closing in on the second decade of a drug shortage crisis that has primarily centered on the persistent and extended interruptions in the supply of hundreds of generic medications.

As a result, we must re-examine our traditional perspective that it is always easy to create generic drugs and always hard to create biosimilars. We have learned that all pharmaceuticals require a great degree of due diligence and commitment to quality. Perhaps the modest barriers to generic entry have been too low to ensure a long-term and consistent availability of high-quality small molecule drugs. Rather than stopping biosimilar development, we should use this ongoing experience to improve our understanding of safe, effective, and sustainable manufacturing for all medications.

A Holistic Approach to Enter the New Year

We are still early in the biosimilars experience and are continuing to make strides in addressing many of the challenges that have slowed and diluted the extent of financial impact. Even with these challenges, the future of biosimilars looks exceedingly bright. According to a report by Global Market Insights, by 2025 the global biosimilars industry is poised to surpass a valuation of $69 billion. However, that will be merely a dream if we are unable to address those hurdles. So what are our next steps? 

Physicians and other clinicians need to understand the concepts of risk management to avoid unnecessary apprehension. If clinicians become more comfortable with the analytical characterization methods to monitor changes in biologics, we move closer to a day when redundant clinical studies are no longer required.

The manufacturing of biosimilars must be monitored closely to avoid any negative impact on product quality. An increased degree of scrutiny of small molecule drugs, including generics, is also important.

We must continue to leverage our advocacy capabilities to remove additional barriers such as the use of excessive patenting to delay the introduction of competition.

Long-term resolution to our challenge of lowering the cost of medications must at some point address the way in which providers are reimbursed. As long as physicians and other providers are reimbursed in a way that higher acquisition costs lead to larger reimbursement opportunities, acceptance of competing products, biosimilars or other, will continue to be limited.

Hurdles to a vibrant biosimilar market are not as insurmountable as they appear.

Understanding the Risks, Opportunities, and Prospects of Biosimilars in 2020 and Beyond

Steven Lucio, PharmD, BCPS

Mauricio Rubio is a pharmacist with advanced studies in administration, and he is currently a master of business administration candidate. He has 13 years of experience in sales, marketing, and business development in Latin America for pharmaceutical and consultancy companies. He has participated as a speaker in the Jack Leckerman Biosimilars Forum in 2018 and 2019.

Mauricio Rubio

Carlos Sattler, MD, is the head of clinical development and medical affairs at Sandoz, Inc. In this capacity, Sattler leads efforts in the United States to develop and implement Sandoz’s medical and scientific strategy, medical education and communication initiatives, and data-generation activities in support of biosimilars and other Sandoz products. Sattler specialized in pediatric medicine and is subspecialty trained in pediatric infectious diseases.

Authors