Comparison of the U.S., Europe, and other Key Markets and Regulatory Harmonization for Biosimilars
Wednesday, November 9, 2022
1:30 p.m. - 3:00 p.m.
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
Jessica Greenbaum, JD
Counsel, King & Spalding LLP
Director, Regulatory Policy & Intelligence, Teva Pharmaceuticals
Stacey Ricci, MEng, ScD
Director, Scientific Review Staff, OTBB, OND, CDER, FDA