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Fast Facts about Extrapolation for Biosimilars - Amgen Science
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This video provides a brief explanation of the basic tenets of extrapolation as it pertains to biosimilars.
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Biologics must demonstrate safety and effectiveness in clinical trials to gain approval for each clinical use. Extrapolation is how these biosimilar products gain the same approval as the generic product it is meant to replace. Extrapolation is based on all available data for the biosimilar, the FDA's other findings for the reference drug, and knowledge and consideration of various scientific factors for each indication. Extrapolation reduces the amount of study needed to approve a proposed biosimilar, making it easier to get it approved for the reference product.
More about Amgen Research:
Learn more at:
Biologics must demonstrate safety and effectiveness in clinical trials to gain approval for each clinical use. Extrapolation is how these biosimilar products gain the same approval as the generic product it is meant to replace. Extrapolation is based on all available data for the biosimilar, the FDA's other findings for the reference drug, and knowledge and consideration of various scientific factors for each indication. Extrapolation reduces the amount of study needed to approve a proposed biosimilar, making it easier to get it approved for the reference product.