Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs (English, HTML)

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HTML

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Publisher-reported update

2022-06-07

This guidance document applies to all biologic drug submissions where the sponsor seeks authorization for sale based on demonstrated similarity to a previously approved biologic drug and relies, in part, on prior information regarding that biologic drug in order to present a reduced clinical and non-clinical package as part of the submission.

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