Public Citizen Comments on Proposed FDA Guidance on Labeling for Biosimilars

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Public Citizen supports the Food and Drug Administration’s (FDA’s) proposal to keep the labels of biosimilars free of data from clinical trials used to demonstrate biosimilarity, similar to the labeling approach taken with generic drugs. We also support the FDA’s proposal to require that manufacturers of biosimilars promptly update the labeling of such products with new safety and efficacy information, as this policy will allow important new warnings to reach patients and doctors promptly.