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.
Document Name |
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Justification for No Material/Nonsubstantive Change |
Supporting Statement A |
Approved without change |
No material or nonsubstantive change to a currently approved collection | 2021-01-27 | |
Approved without change |
Extension without change of a currently approved collection | 2018-12-06 | |
Approved without change |
Extension without change of a currently approved collection | 2015-07-08 | |
Approved without change |
New collection (Request for a new OMB Control Number) | 2012-06-08 |
Federal Enterprise Architecture: Health - Consumer Health and Safety