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Inflammation Biosimilars: Examining the Totality of Evidence for Approval

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Inflammation Biosimilars: Examining the Totality of Evidence for Approval

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Join us as we explore how and why totality of evidence plays an important role in the development and approval process for inflammation biosimilars.

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  • Overview

    The inflammation biosimilar development process uses a stepwise approach with increasing certainty to generate the totality of evidence, which demonstrates the safety, purity, and potency in one or more appropriate conditions of use for which the reference product is licensed.1,2 Dive further into the role of totality of evidence in the inflammation biosimilar development and approval process with Dr. Gil Melmed, Director of Inflammatory Bowel Disease Clinical Research at the Cedars-Sinai and Professor of Medicine at Cedars-Sinai and at the David Geffen School of Medicine at University of California, Los Angeles. Dr. Melmed was compensated for participating in this program. 

    References:

    1. US Food and Drug Administration. Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product Guidance for Industry. Published online April 2015. Accessed March 22, 2023. https://www.fda.gov/media/135612/download

     

    1. US Food and Drug Administration. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product Guidance for Industry. Published online April 2015. Accessed March 22, 2023. https://www.fda.gov/media/82647/download

    ©2023 Amgen Inc. All rights reserved. USA-CBU-81605 5/23

Schedule12 Jul 2024