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FDA: Biosimilar Labeling Should Rely On Innovator Data

This article was originally published in Scrip

Executive Summary

The labeling for biosimilars should rely largely on the relevant safety and effectiveness data used by the corresponding US-licensed innovator medicines, with appropriate product-specific modifications, the FDA said in a new long-awaited draft guidance document issued on March 31 – declaring that's the best approach the agency could come up with after six years of trying.

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