Biosimilar Approvals Are Expected to Undergo Upward Trend in 2022

• by Angela Maas The FDA approved only four biosimilars in 2021, down from its high of the 10 it approved in 2019, but slightly more than the three such therapies approved in 2020. The agency also granted interchangeability to the first two biosimilars. This year may up the excitement level, industry experts tell AIS, with numerous products expected to be approved, while other noteworthy therapies will lose patent protection and potentially face biosimilar competition.  Dea Belazi, Pharm.D., M.P.H., president and CEO of AscellaHealth:  There are six biosimilars with potential launches next year, including [for AbbVie Inc.’s] Humira 100 mg, [Biogen’s] Tysabri, [Roche Group member Genentech USA, Inc.’s] Avastin, [Novo Nordisk’s] NovoLog, [Genentech’s] Lucentis and [Amgen Inc.’s] Neulasta.   If launched, these products will help drive biosimilar adoption and cost-savings opportunities for both patients and payers.  The complexities related to the manufacturing of biosimilar drugs is one major drawback that can restrict market growth in this space. Moreover, lack of awareness regarding the availability of biosimilars among the population is a potential factor that may hamper the projected market growth.    Bill Dreitlein, senior director of pipeline & drug surveillance at Optum Rx:  Pharmacy care services organizations like Optum Rx leverage competition among prescription drug products to reduce costs for patients. Increasing competition through the approval of more brand, generic and biosimilar drug competitors will enable organizations to more effectively lower prescription drug costs for patients, employers, government programs and others.  Facilitating understanding of biosimilars, along with making it harder for drugs and biologics to gain exclusivity, are important steps to expanding the adoption of biosimilars and reducing overall drug costs.  Patient and provider comfort is still a critical barrier. We have seen an increase in prescriber and patient education. For new-to-therapy patients, we are there, but for existing patients, in some certain disease states, switching therapies where patients are already stable can be a difficult decision.  Nicole Kjesbo, Pharm.D., B.C.P.S., clinical program development director at Prime Therapeutics LLC:  There are multiple biosimilars in the pipeline that could join Pfizer’s Zirabev and Amgen/Allergan’s Mvasi as Avastin’s biosimilars. That should create more competition and decrease pricing.   Multiple Humira biosimilars may be approved in 2022 joining the bunch that have already been approved, none of which can launch until 2023. AVT02 from Alvotech/Teva is seeking FDA approval and will seek interchangeability with Humira as well.  One biosimilar that has been approved for Lucentis is Samsung Bioepis’ Byooviz, and one other is set for an FDA decision in 2022. Both are expected to launch in 2022. Although there may be an approval of an Eylea [from Regeneron Pharmaceuticals, Inc.] biosimilar in 2022, Eylea biosimilars are unable to launch until either 2024 or 2032 pending patent litigation.  From Radar on Specialty Pharmacy Subscribers may read the in-depth article online. Learn more about subscribing to AIS Health's publications.