February 18, 2016 12:00 PM
Lectures and Panels
2015-2016
Pound Hall, Room 100
Harvard Law School, 1536 Massachusetts Ave., Cambridge, MA

VIDEO: Introduction, Holly Fernandez Lynch
VIDEO: Donald R. Ware, Background and Context
VIDEO: Moderated panel discussion
VIDEO: Audience Q&A

Couldn't attend the event? Check out some of our speakers' slide presentations!

Description

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

Learn More

Couldn't attend the event? Check out some of our speakers' slide presentations!

This event was free and open to the public.

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

Videos

VIDEO: Introduction, Holly Fernandez Lynch
VIDEO: Donald R. Ware, Background and Context
VIDEO: Moderated panel discussion
VIDEO: Audience Q&A

Tags

biotechnology   fda   health law policy   innovation   international   pharmaceuticals   rachel sachs   regulation   w. nicholson price ii