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Session 1: Emerging Approaches to Demonstrating Structural and Functional Similarity
Session Chair(s)
Emily Shacter, PhD
Independent Consultant
ThinkFDA, LLC, United States
This session will address the tools used for the demonstration of similarity based on biochemical, physicochemical, and functional comparison of a proposed biosimilar to a reference product. Presentations and a panel discussion will provide data and insights on the use of state of the art analytical techniques and biological assays that can identify and quantify molecular similarity and differences. The use of quantitative approaches for evaluation of the similarity data, as well as application of scientific considerations to the acceptability of observed differences, will be discussed.
Learning Objective :
Speaker(s)
Speaker
Patrick J. Lynch
U.S. Food and Drug Administration, United States
Biologist, Product Quality Reviewer
Speaker
Martin Schiestl, PhD
Sandoz GmbH, Austria
Global Head Regulatory Affairs Policy
Speaker
Elizabeth Pollitt, PhD
BioPharma CMC Regulatory Consultancy Services, Ltd., United Kingdom
Director
Speaker
Kyung-Ah Kim, PhD
Samsung Bioepis, Korea, Republic of
Vice President, Head of Bioanalysis