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[V8-S4] Clinical Development of Biosimilar Products
Session Chair(s)
Teruyo Arato, PHD
Professor, Clinical Research and Medical Innovation Center, Hokkaido University Hospital, Japan
Biosimilar products have been actively developed globally, and it has been widely discussed how to evaluate the biosimilarity with reference product. This session will focus mainly on scientific considerations of clinical development and clinical trial for biosimilar products. Speakers will introduce key features of clinical data package and study design in the development of biosimilar products. In addition, some statistical issues will be discussed. We would also like to discuss the differences of approaches among countries/regions, which could be the challenges in global development.
Speaker(s)
Yuko Kawakita, RPH
Manager, Regulatory Affairs, Daiichi Sankyo Co., Ltd., Japan
Biosimilar Challenges from the Point of View of Project Management
Duu-Gong Wu, DRSC, PHD
Senior Director, Global Regulatory Affairs, PPD, United States
Regulatory and Scientific Issues on Biosimilar Development in the U.S: Lessons Learned from Recent Approvals
Nan Zhang, PHD
Biostatistics Manager, Amgen Inc., United States
Statistical Considerations for the Development of Biosimilar Products
Kota Tokushige, MS
Oncology Development & Medical Affairs Department, Novartis Pharma K.K., Japan
Comparative Clinical Study Designs for Biosimilar Development Program