Regulatory And Legislative Actions Set The Tone For Biosimilars In 2021
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 increase...
Source: pharmaceuticalonline.com