FDA Biosimilar Approval Recap – 2021

By Kevin E. Noonan — The U.S. Food and Drug Administration approved four biosimilar drugs in 2021 under the provisions of the Biologics Price Competition and Innovation Act (BPCIA, codified at 42 U.S.C. § 262) as part of the Affordable Care Act of 2010 (colloquially known as "Obamacare"). This brings to 33 the total number of approved biosimilars, although the effects of the pandemic has been felt in the last two years. From 2015 (when there was only a single approved biosimilar, Sandoz’s Zarxio®, see chart below), the rate of approvals rose every year (3 in 2016, 5 in 2017,…