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Hyatt Regency Bethesda

2015 年 10 月 19 日 7:00 上午 - 2015 年 10 月 20 日 4:30 下午

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

Biosimilars 2015

Interact with FDA and international agencies to discuss the latest updates and outlooks for biosimilar regulation, while examining the potential implications for patients and HCPs.

Session 7: Interchangeability

Session Chair(s)

Cecil J. Nick, MS

Cecil J. Nick, MS

FTOPRA, Vice President (Technical)

Parexel Consulting, United Kingdom

Biosimilar access and adoption is dependent on Biosimilars being available in the market place. A wide variety of commercial models exist varying from national tendering through to individual commercial plan acceptance. These models will be variously impacted by or will impact the concepts of interchangeability, switching and substitution. The session will also address the practical differences between each of these terms. It will specifically address regulatory considerations/ expectations related to interchangeability and the impact of such designation on the future market place dynamics and adoption. Scientific concepts and their application to achieve interchangeability designation will be discussed.

Speaker(s)

Hillel P Cohen, PhD

The Science of Interchangeability

Hillel P Cohen, PhD

Sandoz Inc., United States

Executive Director, Scientific Affairs

Tom B. Snyder, MA

A Payer's Perspective

Tom B. Snyder, MA

Parexel International, United States

Senior Project Manager

Jim  Roach, MD, FACP

Interchangeability: Is it Achievable? Will it Matter?

Jim Roach, MD, FACP

Pulmatrix, United States

Chief Medical Officer

All Session  Speakers

Panel Discussion

All Session Speakers

United States

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