Because of the recently defined regulatory pathways for biosimilars, there has been a huge rise in the number of biosimilar products in development.Thorough characterization of a biosimilar candidate in comparison with the reference product is the basis for a targeted clinical development program. FDA biosimilar guidelines suggest not only to analyze isolated quality attributes but also to focus on combinations of quality parameters. So what is the current status?Session: FDA Perspective - Update on the United States Biosimilars Program
Speaker: Jeffrey C. Baker, Ph.D., Deputy Director, Office of Biotechnology Products (OBP), CDER, US FDA
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