Follow-On Biologics: The Latest FDA, FTC, and Intellectual Property Developments

Biosimilars (or follow-on biologics) are a hot topic these days – and getting hotter – whether one talks about FDA’s draft guidance documents (see here), battles brewing in state legislatures around the country concerning substitution (see here), the flurry of citizen petitions submitted to FDA concerning biosimilar naming (see here), controversy concerning the “patent dance” procedures of the Biologics Price Competition and Innovation Act of 2009 (see here), or the applicability of the BPCIA to older biological products (see here).  

On February 4, 2014, the Federal Trade Commission (“FTC”) will hold a workshop addressing some of these issues: “Follow-On Biologics Workshop: Impact of Recent Legislative and Regulatory Naming Proposals on Competition.”  (The final agenda for the February 4th workshop was announced earlier this week.)  And just two days later, on February 6, 2014, from 12:00-1:00 PM EST, experts from Hyman, Phelps & McNamara, P.C. and Dechert LLP will discuss the implications of and issues with the new biosimilar approval process created by the BPCIA and other major takeaways from the FTC workshop.  Topics to be covered during the February 6th webinar will include: (1) Current status and next steps for the FDA’s implementation of a biosimilar approval process; (2) Major takeaways from the FTC’s February 4 workshop on biologics; and (3) Intellectual property issues in the run-up to the first biosimilar approval. 

Registration for the webinar is free and can be made here.  Webinar speakers include Hyman, Phelps & McNamara, P.C.’s James C. Shehan and Dechert LLP’s Daniel M. Becker, M.D., Mike Cowie, and George G. Gordon.  Please confirm your webinar attendance by February 5, 2014.  Further details, including how to connect to the webinar, will be provided closer to the program.