General Licensing Provisions; Section 351(k) Biosimilar Applications

OMB 0910-0719

OMB 0910-0719

The information collection establishes an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product, and sets forth the requirements for an application for a proposed biosimilar product and an application or a supplement for a proposed interchangeable product. The information submitted in a 351(k) application or supplement is used by FDA to make a determination of biosimilarity or interchangeability of a proposed 351(k) product.

The latest form for General Licensing Provisions; Section 351(k) Biosimilar Applications expires 2022-01-31 and can be found here.

OMB Details

Biosimilar Product Applications - 351(k)(2)(A)(i) and (k)(2)(A)(iii)

Federal Enterprise Architecture: Health - Consumer Health and Safety


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