FDA targets faster reviews for biosimilar supplements, draft guidance says
The FDA on Thursday published new draft guidance explaining how it will speed its review of biosimilar or interchangeable application supplements, which can be used to update the initial biosimilar approval when it is for fewer than all the reference product’s licensed conditions of use.
The 9-page draft details how FDA cannot license a biosimilar or interchangeable product for an indication protected by orphan-drug exclusivity or pediatric exclusivity until the expiration of that exclusivity. Applicants also may decide not to seek licensure of a proposed biosimilar or proposed interchangeable product for conditions of use that are protected by a patent or for other reasons.
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