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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 6: Pushing Well Forward - Commercialization of Biosimilars Post-2020

Session Chair(s)

Geoff  Eich

Geoff Eich

Executive Director, External Affairs

Amgen Biosimilars, United States

This discussion will focus on the post-2020 U.S. biosimilars market and considerations for sustained biosimilars development of increasingly complex and/or rare disease biologic reference products. Topics will include implications of innovation in biosimilar markets (e.g. treatment of breast and colorectal cancers) and selection of viable reference products for biosimilars development. Panelists will be asked to address important policies and considerations related to the approval, post-market maintenance, healthcare community acceptance and reimbursement of highly complex and/or rare disease biosimilar medicines post-2020.

Speaker(s)

Aharon  Gal, PhD

Panelists

Aharon Gal, PhD

Sanford C Bernstein, United States

Senior Research Analyst

Leah  Christl, PhD

Leah Christl, PhD

Amgen, United States

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

Steven  Kozlowski, MD

Steven Kozlowski, MD

FDA, United States

Director, Office of Biotechnology Products, OPQ, CDER

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