Petrie-Flom Center | Assessing the Viability of FDA’s Biosimilar Pathway

The 2010 passage of the Biologics Price Competition and Innovation Act was intended to create a pathway for the approval of biosimilar drugs, to bring to market less expensive versions of innovators’ biologic therapeutics in the same way the Hatch-Waxman Act has worked so well for FDA approval of generic small-molecule drugs. But the Act has been mired in a host of statutory, regulatory, and scientific complication and delays, and five years later, the FDA has approved just one biosimilar product.

This panel brought together experts from legal practice, industry, and academia to discuss each of these issues and to recommend ways in which the agency and industry can move forward.

Panelists:

– Donald R. Ware, Partner, Foley Hoag LLP
– Konstantinos Andrikopoulos, Lead IP Counsel, Biogen, Inc.
– W. Nicholson Price II, Assistant Professor of Law, UNH School of Law
– Moderator: Rachel E. Sachs, Academic Fellow, Petrie-Flom Center

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.