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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)
Biosimilar Challenges from the Point of View of Project Management
Yuko Kawakita, RPh
Daiichi Sankyo Co., Ltd., Japan
Manager, Regulatory Affairs
Regulatory and Scientific Issues on Biosimilar Development in the U.S: Lessons Learned from Recent Approvals
Duu-Gong Wu, DrSc, PhD
PPD, United States
Senior Director, Global Regulatory Affairs
Statistical Considerations for the Development of Biosimilar Products
Nan Zhang, PhD
Amgen Inc., United States
Biostatistics Manager
Comparative Clinical Study Designs for Biosimilar Development Program
Kota Tokushige, MS
Novartis Pharma K.K., Japan
Oncology Development & Medical Affairs Department
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