Learning Tracks

Enacted in 2012, the Biosimilar User Fee Act (BsUFA) authorizes FDA to assess and collect fees for biosimilar biological products which ultimately helps to get more biosimilar medicines to patients more quickly. The law must be renewed every five years, including a negotiation between industry and the FDA and reauthorization of the law by the U.S. Congress. In this session, panelists from AAM’s membership who participated as industry negotiators will explore the changes we can anticipate during BsUFA IV (tentatively effective October 1, 2027).

Jessica Greenbaum, JD
Director, Regulatory Affairs Policy U.S., Sandoz Inc.

Scott Tomsky, MS
Vice President, Global Head, Regulatory Affairs, Biocon Biologics

Cory Wohlbach
Global Vice President Biosimilar Regulatory Affairs, Teva Pharmaceuticals

Andrew Zacher, JD, MS
Senior Director, Regulatory & Public Policy, Amneal Pharmaceuticals