Learning Tracks

How would global regulatory harmonization for biosimilars make biosimilars more available to patients in the United States? To what extent are divergent regulatory frameworks adding to the cost and time to develop biosimilars? This session will include a discussion of what a harmonized global development and regulatory paradigm should look like and what’s needed to get there as well as the steps already taken to streamline biosimilar development in non-U.S. markets. In addition, this session will look at the hurdles to developing biosimilars for multiple markets and what regulatory or other solutions could improve the availability and increased use of biosimilars globally.

Moderator: Steve Selde
Director, Biosimilars Council, AAM

Speakers:

Jessica Greenbaum, JD
Counsel, King & Spalding LLP

Aaron Josephson
Director, Regulatory Policy & Intelligence, Teva Pharmaceuticals

Stacey Ricci, MEng, ScD 
Director, Scientific Review Staff, OTBB, OND, CDER, FDA