Learning Tracks

The United States’ framework for biosimilars regulation is unique in that it requires companies obtain a separate regulatory designation of interchangeability for products that companies wish to be able to have substituted at the pharmacy without prescriber intervention. This session will include a discussion of whether this additional regulatory hurdle is scientifically justified considering the benefits and risks of all biologic medicines. Through this session, attendees will understand the challenges related to interchangeability designations in the US, including why other countries do not have a separate regulatory designation for interchangeability and the scientific justification for and against it.

Moderator: Michael Brzica, JD
Vice President, Government Affairs, Teva Pharmaceuticals

Speakers:

Hillel Cohen, PhD
Executive Director, Scientific Affairs, Sandoz Inc.

Geni Tunstall, JD
Director of Regulatory Affairs, AMCP

Rachel Turow, JD, MPH
Associate General Counsel, Regulatory Law & Policy Head, U.S. Regulatory Policy, Teva Pharmaceuticals