Biosimilar Approvals Are Expected to Undergo Upward Trend in 2022

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, a division of MMIT, 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: The United States has been slow to approve and adopt biosimilars. Since the initial biosimilar approval in 2015, the FDA has approved 33 biosimilars, but only 18 are currently available on the U.S. market with a projected market value of $13 billion in 2021. Even with this slow uptake in the United States, there is increased utilization and a growing pipeline of products that will drive use and savings. In 2021, many blockbuster drugs were approved in the biosimilar space, along with the two interchangeable biosimilar products, [Boehringer Ingelheim Pharmaceuticals, Inc.’s] Cyltezo and [Viatris Inc. and Biocon Ltd. subsidiary Biocon Biologics Ltd.’s] Semglee.

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Angela Maas

Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. She also has written for Spotlight on Market Access since its 2017 launch. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at Hem Aware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.

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