How Similar is Biosimilar? – Introducing Draft Guidance for Industry on Biosimilars by the U.S. FDA

May 9, 2012
The 14th Shanghai International Forum on Biotechnology & Pharmaceutical Industry (BIO-FORUM)
The Shanghai International Convention Center
Jerry Liu presented FDA’s new Draft Guidance on biosimilar products in the implementation of the Biologics Price Competition and Innovation Act of 2009 (the “BPCI Act”), and provided insights on the regulatory and intellectual property aspects of the biosimilar industry through comparing and/or contrasting the new Draft Guidance with the corresponding guidance governing the small-molecule generic drug industry in the implementation of the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”).