Business
The ninth installment of Ropes & Gray’s podcast series, Non-binding Guidance, focuses on changes to the FDA regulation of certain products pursuant to the “Deemed to be a License” provision, also known as the transition provision, of the Biologics Price Competition and Innovation Act (BPCIA). On the transition date of March 23, 2020, around 90 insulin and other protein products currently regulated as drugs will be deemed to have Biologic License Applications and subject to regulation as biological products. In this episode, life sciences regulatory and compliance attorneys Kellie Combs and Deborah Cho are joined by Filko Prugo, chair of the life sciences IP litigation group, to discuss the transition provision and its anticipated impacts on regulatory exclusivity, patent litigation, and the biologics and biosimilars market.