Regulatory And Legislative Actions Set The Tone For Biosimilars In 2021
By Philip Chen, Kayleigh McGlynn, and Jenny Shmuel, Fish & Richardson P.C.
The abbreviated biosimilar licensure pathway created by the Biologics Price Competition and Innovation Act (BPCIA) in 2010 was designed to increase competition for biologics and reduce healthcare costs. Already, FDA has licensed almost 30 biosimilars, nearly 20 of which are available to patients in the United States. While 2020 saw a slowdown in FDA approvals and biosimilar product launches from previous years, market uptake of biosimilars increased and more biosimilars are sure to come. FDA has reported numerous biosimilar-related submissions in its pipeline for Fiscal Year (FY) 2020, including seven original biosimilar biologics license application (BLA) submissions in FY 2020. As of FY 2020 Q4, there were 84 biosimilar development programs enrolled in the biosimilar biological product development (BPD) program. In addition, with the B