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Session 4: How Will BsUFA II Modify the Development and Approval of Biosimilars in the US?
Session Chair(s)
Thomas Felix, MD
Medical Director, R&D Policy, Global Regulatory Affairs and Safety
Amgen Inc., United States
FDA and industry have recently negotiated a series of enhancements to the Biosimilars User Fee Act (BsUFA II). These include a revised review process meant to increase transparency and to facilitate an increase in the likelihood of first-cycle approvals; FDA commitments to complete and publish several draft and final guidance documents; FDA commitments to strengthen staffing levels of the biosimilars program; and enhancements to the user fee structure and management that will allow greater transparency, predictability, and long-term stability of biosimilar development programs in the US. This session will review these enhancements and the impact they are intended to have on the development and approval of biosimilars in the US.
Learning Objective :
Speaker(s)
Speaker
Leah Christl, PhD
Amgen, United States
Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy
Speaker
Bruce Leicher, JD
Momenta Pharmaceuticals, Inc., United States
Senior Vice President and General Counsel
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