Welcome to the most recent quarterly update surrounding biologics and biosimilars, with specific focus on post-grant and patent litigation challenges to globally recognized biologics. A note of interest: since the implementation of the Biologics Price Competition and Innovation Act (BPCIA), 43 biosimilars have received approval, with 37 having officially launched.
The BPCIA has played a crucial role in shaping the landscape of biologic and biosimilar treatments. It not only provides a regulatory pathway for biosimilar and interchangeable biological products but its implementation has also ignited an uptick in litigation relating to biologics and biosimilars.
Since the last update, there has been a significant development in biosimilar-related litigation: Genentech and Biogen have reached a settlement in a lawsuit relating to Biogen’s biosimilar to Actemra. For the complete insights on the topic, consider reading the
the full publication by Morgan Lewis.
Stay tuned to this platform for future updates on legal advancements and rulings in the complex and rapidly evolving field of biologics and biosimilars.