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DoubleTree Bethesdan

Sep 23, 2019 7:00 AM - Sep 24, 2019 5:00 PM

8120 Wisconsin Avenue, , Bethesda, MD 20814 , USA

Biosimilars Conference

Session 7: Switching and Substitution of Biological Products

Session Chair(s)

Laura  McKinley, PhD

Laura McKinley, PhD

Director, Global Regulatory Policy and Intelligence

Pfizer Inc, United States

The term interchangeable has different meanings in different parts of the world. The session will begin with a brief review of terminology, including differences in US and EU definitions of interchangeability, and what has changed in the US with the finalization of guidance. The session will go beyond discussing the regulatory frameworks that support switching and substitution of biological products. The session will discuss the science supporting switching and substitution of biological products, experience to date with a focus on the US marketplace, and the anticipated value and impact of the interchangeability designation in the US.

Learning Objective : Upon completion of this session, the participant should be able to:
  • Understand the meaning of interchangeability in US and EU
  • Understand the difference between physician-mediated switching and pharmacy-level substitution
  • Gain a broad understanding of the considerations influencing the value of interchangeability in the US marketplace


Laura  McKinley, PhD

The Current State of Affairs: Switching, Substitution, and Interchangeability

Laura McKinley, PhD

Pfizer Inc, United States

Director, Global Regulatory Policy and Intelligence

Hans  Ebbers, PhD

The Science of Substitution

Hans Ebbers, PhD

Biogen Netherlands B.V. , Netherlands

International Scientific Affairs

Sameer  Awsare, MD

US Experience to Date

Sameer Awsare, MD

Permanente Medicine, The Permanente Medical Group, United States

FACP Associate Executive Director

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