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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
Biologist, Product Quality Reviewer, U.S. Food and Drug Administration, United States
Speaker
Global Head Regulatory Affairs Policy, Sandoz GmbH, Austria
Speaker
Director, BioPharma CMC Regulatory Consultancy Services, Ltd., United Kingdom
Speaker
Vice President, Head of Bioanalysis, Samsung Bioepis, Korea, Republic of
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