On Tuesday, July 23, Knobbe Martens hosted a live webinar event covering “Preparing for Biosimilars: Key Points for Participating in the U.S. Regulatory Framework.” Partners Eli Loots, Carol Pitzel Cruz, and Sheila Swaroop participated as panelists, along with Michael Fuller as the moderator.
In view of the U.S. approval process for biosimilars, companies are gearing up to either produce their own biosimilar products, or to defend against their entry onto the market. While the Biologics Price Competition and Innovation Act (BPCIA) spells out many of the requirements, the pathway for approval is complicated. Our panel of attorneys discussed the features of the BPCIA and how it operates for both approved biologics as well as biosimilar entrants. They also made some predictions on its impact for life science companies. The webinar was 60 minutes, complete with Q&A.
View below for a recording of the webinar:
Preparing for Biosimilars: Key Points for Participating in the U.S. Regulatory Framework from Knobbe Martens on Vimeo.
View below for a copy of the webinar slides:
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