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Session 1: Statistical Issues in Biosimilar Analytical Assessment
Session Chair(s)
Stella C. Grosser, PHD, MS
Division Director, Office of Biostatistics, OTS, CDER
FDA, United States
Eric M. Chi, PHD
Executive Director
Amgen, United States
As some biologics are reaching the end of their patent, a sponsor may pursue “similar” biological products for marketing approval. The sponsor needs to demonstrate that the test products are biosimilar to the reference products in a three-stage process. Analytical assessment, as the first stage, becomes extremely important. Due to the limited sample size (number of lots) and numerous, some quite complex, quality attributes, the statistical “similarity” comparison is difficult, with multiple issues arising.
The objective of this session is for statisticians from regulatory agencies, academia and industry to share their knowledge and experience, and to cultivate skills and paths leading to successful development of biosimilar products. The session will consist of 3 oral presentations followed by a panel discussion led by organizers and speakers.
Speaker(s)
Speaker
Yi Tsong, DRSC, PHD
FDA, United States
Director, Division of Biometrics VI, Office of Biostatistics, OTS, CDER
Speaker
Rick Burdick
Amgen, United States
Quality Engineering Director
Speaker
Shein-Chung Chow, PHD
Duke University, United States
Professor, Department of Biostatistics and Bioinformatics, School of Medicine