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Session 3 / Venue 4: Regulation, Development, and Future of Biosimilars
Session Chair(s)
Teruyo Arato, PhD
Professor, Clinical Research and Medical Innovation Center
Hokkaido University Hospital, Japan
Regulatory guidance, development and regulatory path for approval, and use of Biosimilar products are underway. And larger products such as antibody product become target to develop. The questions arises on these type of product position such as whether Bio-similar should be accelerate, whether requirement on clinical studies, whether difference exist among ICH regions and/or non ICH regions, whether reference products position are agreed. On the other hand, innovative license holder moves against Bio-similar products by extensive LCM including bio-better aspects. Discussion should cover patients first and health economy aspects to lead understanding of these new category of biologics products.
Speaker(s)
Regulatory Status of biosimilar in Japan
Reiko Yanagihara, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Deputy Review Director, Office of In Vitro Diagnostics
Does the MHLW biosimilar guideline need an update? A look at the regulatory situation in Japan, Europe and US
Martin Schiestl, PhD
Sandoz GmbH, Austria
Global Head Regulatory Affairs Policy
Opinions from Generic Drugs Developer
Hideaki Nomura
Fujifilm Kyowa Kirin Biologics Co., Ltd., Japan
President & CEO
Review and approval system of Biosimilar Products in Korea
Young-Eun Kim, PhD
National Institute of Food and Drug Safety Evaluation (NIFDS), Korea, Republic of
Scientific Officer, Recombinant Protein Products Division
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