Health Care Reform Includes Biologics Price Competition and Innovation Act of 2009

April 19, 2010

Clears Path for Follow-on Biologic Competition, Raises New and Familiar Antitrust Issues

The Biologics Price Competition and Innovation Act of 2009 recently signed into law clears a regulatory path for expedited entry of “biosimilar” versions of branded biological products (called “follow-on biologics” or “FOB products”). This update reviews the Biologics Act, which will profoundly impact competition between biotechnology firms in the development, manufacture, and sale of biologic products.