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Session 7: Satistical Considerations in Development of Biosimilar Products
Session Chair(s)
Roger (Peng) Qu, PhD
Head of Clinical Statistics
Pfizer China R&D Center, China
Speaker(s)
Case Studies: Zarzio – a filgrastim biosimilar; Remsima – an infliximab biosimilar
Eric M. Chi, PhD
Amgen, United States
Executive Director
Design and Analysis of Clinical Studies for Follow-on Biologics
Shein-Chung Chow, PhD
Duke University, United States
Professor, Department of Biostatistics and Bioinformatics, School of Medicine
Policies and Guidelines for Evaluation of Biosimilars EMA/WHO/FDA
Eric M. Chi, PhD
Amgen, United States
Executive Director
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