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'Authorized Biosimilars' Cannot Use 351(k) Pathway

FDA Concludes Reference Product Must Be Another Biological Product

Executive Summary

FDA's position will impact what types of biosimilar and interchangeability applications can be submitted for insulin and other "deemed" protein products. Agency says in final draft Q&A guidance on transition provisions that the holder of a standalone BLA cannot reference its own product in an application for a bisoimilar or interchangeable version.

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