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Virtual Event

Oct 06, 2020 10:00 AM - Oct 07, 2020 5:25 PM

(US Eastern Standard Time)

Fort Washington, PA 19034

Biosimilars Conference

Welcome, Opening Remarks, and Keynote Address

Session Chair(s)

Robin M. Weinick, PhD

Robin M. Weinick, PhD

SVP/Managing Director Americas and Global Program Officer

DIA, United States

Hillel P Cohen, PhD

Hillel P Cohen, PhD

Executive Director, Scientific Affairs

Sandoz Inc., United States

Ten years after the implementation of the Biologics Price Competition and Innovation (BCPI) Act, biosimilars are beginning to gain traction in the US. The leadership of FDA in establishing a pathway to demonstrate biosimilarity or interchangeability has been important in ensuring that these therapies can be made available to patients. Dr. Stein will share his perspective on the status of biosimilars in the US and important efforts that the Agency and other stakeholders can make to continue increasing access and acceptance of these therapies by patients and their healthcare providers.

Speaker(s)

Peter P. Stein, MD

Peter P. Stein, MD

FDA, United States

Director, Office of New Drugs, CDER

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