Regulatory Models for Biosimilars

On Monday, September 14, 2009 Foley Partner David Rosen will participate in a panel presentation at the Regulatory Affairs and Professionals Society (RAPS) 2009 Annual Conference and Exhibition. The panel, “Regulatory Models for Biosimilars,” will brief participants on the progress of pending bills in Congress that may provide a statutory path for biosimilars as the 1984 Hatch-Waxman Act did for drugs. The European regulatory system’s approach to generic biologics and techniques for proving bioequivalence with products that appear similar, but present significant variations in immunogenicity will be discussed.

The session leader is Joel Falk, Executive Vice President, The Weinberg Group and also participating on the panel is Sandra Dennis, deputy general counsel for healthcare, Biotechnology Industry Organization (BIO)

To view more details regarding this presentation, please visit the RAPS site.