As pressure mounts on the U.S. Congress and the White House to curtail prescription drug prices, many experts continue to point to biosimilars and their promising potential to usher in competition, increase access, and drive down costs for patients—and the U.S. market is just beginning to heat up.
In the latter half of 2021, there was lots of exciting movement. The Food and Drug Administration (FDA) approved four biosimilars, three of which were industry firsts: leading with Semglee, the first interchangeable biosimilar ever approved; followed by Byooviz, which broke into the ophthalmology/retina space; and then Cyltezo, yet another Humira biosimilar but the first to receive the interchangeable designation. And already in the first quarter of 2022, the FDA approved a third filgrastim biosimilar, Releuko.
With 34 approved biosimilars and dozens more in the pipeline, what does this year have in store? Here are five things I have my eye on in 2022.
The uptake and adoption of Semglee’s two versions
Semglee (insulin glargine-yfgn) is the first biosimilar available at the retail pharmacy counter, and it obtained interchangeable status. So far, select payers have added Semglee to their preferred formularies, including Express Scripts and Prime Therapeutics. And with the availability of two versions—a branded and unbranded version—the industry will watch closely how both products compete in the commercial market versus Medicare Part D plans, and whether any other insurers adopt it to their formularies.
Moreover, manufacturers will see what learnings they can glean from the strategy that manufacturer Viatris has taken and then apply that to other molecules set to enter the retail pharmacy space, specifically the seven approved Humira biosimilars that will all launch in 2023. And, manufacturers will likely pay close attention to the impact of Semglee’s interchangeable designation on the adoption of biosimilars in the retail pharmacy space.
The launch of the first Biosimilar in retina/ophthalmology space
In September of 2021, the FDA approved Byooviz, which references Roche and Novartis’ blockbuster eye drug Lucentis. Its forthcoming launch mid-year makes it the first biosimilar within retina-ophthalmology. Byooviz will introduce direct competition to the reference product for the first time, and there is a potential for an additional ranibizumab biosimilar to launch by the end of the year.
Coherus BioSciences—who also has an approved adalimumab and pegfilgrastim product—is anticipating action by the FDA in August 2022 on its ranibizumab candidate. If its product receives the green light from the federal agency, they plan to launch within a few months following approval.
Experts anticipate that the increased adoption and competition in specialty drug markets will provide a significant cost-saving opportunity for both patients and providers in the long run—just as the generics market did many, many years ago.
Innovator products working to maintain market share
As more biosimilars launch, I continue to observe how manufacturers of innovator products respond to these entrants. For example, Janssen released an unbranded version of Remicade to push back on three biosimilars in the infliximab space. The unbranded version, which is identical to the brand-name product, specifically targets Part B and not commercial plans. So, it will be interesting to watch how this continues to play out.
Additionally, the industry will have to make note of whether Janssen’s move encourages other biologics manufacturers to follow a similar path and decide to release “unbranded biologics” of their blockbuster drugs as a means to hold onto market share.
The entrance of additional manufacturers and therapeutic areas in the pipeline
All of the approvals and pipeline entrants in 2021 indicate to me that the FDA is getting back on track to review biosimilar products, and that the market is clearly expanding. As such, manufacturers—some we have seen before and some new to biosimilars—will likely look to enter into existing and new therapeutic areas, including ophthalmology and the growth hormone space.
As a result, markets are expected to become more competitive, and it will show pharmaceutical companies that there’s ample opportunity to invest in the research and development of biosimilars. Not to mention the benefit it will bring patients, who will have access to alternative treatments that are estimated to save the healthcare system $38.4 billion over the next 5 years.
Humira Biosimilars launching in 2023
Lastly, I cannot write about biosimilars without mentioning Humira. Summer/fall of 2022 is when the industry begins preparation for the watershed moment in 2023—when seven, or possibly more, biosimilars referencing Humira are set to launch.
How will the world’s top-selling prescription drug fare? Many pharmaceutical industry stakeholders will follow this moment closely, with a keen eye on how pharmacy benefit managers (PBM) will consider these multiple adalimumab products. And we’ll also watch how the unprecedented competition in this market will create opportunities and drive potential cost savings for patients. With this many biosimilars entering the retail pharmacy space, a whole new customer group and market will be introduced to this growing group of drugs.
About the author
Elizabeth “Beth” McMahon is senior vice president of emerging therapies & channel strategy at AmerisourceBergen. She works alongside biopharmaceutical companies to ensure lifesaving and life-changing medications reach patients at all points of care.
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