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The Reauthorization of BsUFA and its Impact on Both the Regulator and Industry
Session Chair(s)
Juliana Marguerite Reed, MS
Executive Director
The Biosimilars Forum, United States
FDA and industry have taken lessons learned from the first four years of the biosimilar user fee agreement (BsUFA) and applied them to this first reauthorization of the program. This session will focus on changes to the program and their affect on both industry and the agency.
Learning Objective : Discuss what's new in BsUFA II and the impact on sponsors and regulators.
Speaker(s)
Biosimilar User Fee Act (BsUFA II) Reauthorization: Proposed Agreements
Leah Christl, PHD
Amgen, United States
Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy
Panelist
Hillel P Cohen, PHD
Retired, United States
Biosimilars Expert
Panelist
Kimberly Greco
Amgen Inc., United States
Director, Research and Development Policy
Panelist
John Pakulski, RPH
Kashiv BioSciences LLC, United States
Senior Vice President, Global Regulatory Affairs