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[V4-S1] Points to Consider on the Biosimilar Development - Comparability Evaluation, Interchangeability, Advantage of Biosimilar Development
Session Chair(s)
Teruyo Arato, PhD
Professor, Clinical Research and Medical Innovation Center
Hokkaido University Hospital, Japan
Speaker(s)
Biosimilar Medical Needs and Development in Japan -Experiences and Challenges-
Yoshihiro Nambu, MD, PhD
Nippon Kayaku Co., Ltd., Japan
Member of The Board / Managing Director / Head of Pharmaceuticals Group
Quality of Biosimilar Product - From a Viewpoint of CMC
Katsuya Nishino
JCR Pharmaceuticals Co., Ltd., Japan
Representative Director, Executive Vice President
Considerations on extrapolation of indications
Reiko Yanagihara, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Deputy Review Director, Office of In Vitro Diagnostics
How to Decide the Interchangeability from Innovator Drugs to Biosimilars: Why Can You Switch Or Not?
Susumu Yokoya, MD, PhD
National Center for Child Health and Development, Japan
Vice-Director
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