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Hyatt Regency Bethesda

2017 年 10 月 24 日 7:00 上午 - 2017 年 10 月 25 日 3:30 下午

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

Biosimilars Conference

Session 4: How Will BsUFA II Modify the Development and Approval of Biosimilars in the US?

Session Chair(s)

Thomas  Felix, MD

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 :
  • Describe the program development changes that will be implemented with BsUFA II
  • Describe the resource and financial changes that will be implemented with BsUFA II
  • Discuss how these changes will impact biosimilar development and approval processes
  • Speaker(s)

    Leah  Christl, PhD

    Speaker

    Leah Christl, PhD

    Amgen, United States

    Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy

    Bruce  Leicher, JD

    Speaker

    Bruce Leicher, JD

    Momenta Pharmaceuticals, Inc., United States

    Senior Vice President and General Counsel

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