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Hyatt Regency Bethesda

24 oct 2017 7:00 a.m. - 25 oct 2017 3:30 p.m.

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

Biosimilars Conference

Session 9: Interchangeability

Session Chair(s)

Laura  McKinley, PhD

Laura McKinley, PhD

Director, Global Regulatory Policy and Intelligence

Pfizer Inc, United States

The term “interchangeable,” when applied to biosimilars, has different meanings in different parts of the world. The session will begin with a review of terminology, including differences in US and EU definitions of interchangeability, and regulatory and legal frameworks as they relate to substitution of biologics. The session will then explore the US FDA draft guidance for industry on considerations in demonstrating interchangeability with a reference product, highlighting data expectations, and relaying industry perspectives on demonstrating interchangeability; discussing combination product considerations; and sharing perspectives on value and implementation in the US.

Learning Objective :
  • Explain the meaning of Interchangeability in the US and the EU
  • Describe the difference between physician-mediated switching and pharmacy-level substitution
  • Express a broad understanding of US expectations for demonstration of interchangeability
  • Speaker(s)

    Daniel F Alvarez, MD

    Speaker

    Daniel F Alvarez, MD

    Pfizer, United States

    Senior Director

    Cindy (Yang)  Cao, PhD

    Speaker

    Cindy (Yang) Cao, PhD

    Ascentage Pharma, United States

    SVP, Regulatory Affairs

    Jonah  Houts

    Speaker

    Jonah Houts

    Express Scripts, Inc., United States

    Vice President, Government Affairs

    Daniel  Nam

    Speaker

    Daniel Nam

    America's Health Insurance Plans, United States

    Executive Director of Federal Programs

    Leah  Christl, PhD

    Speaker

    Leah Christl, PhD

    Amgen, United States

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

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