General Licensing Provisions; Section 351(k) Biosimilar Applications

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.

Latest Forms, Documents, and Supporting Material

Document Name
0719 Change Request to include BsUFA performance goals JAN 2021.docx Justification for No Material/Nonsubstantive Change
0719 351k Applications SSA 2018 Ext.pdf Supporting Statement A
BsUFA Performance Goals and Procedures for FYs 2018 THROUGH 2022 Other-Performance Goals
Patent Infringement Notifications - 351(l)(6)(C)
Interchangeable Product Applications or Supplements - 351(k)(2)(B) and (k)(4)
Biosimilar Product Applications - 351(k)(2)(A)(i) and (k)(2)(A)(iii)

All Historical Document Collections

202101-0910-014 Approved without change	No material or nonsubstantive change to a currently approved collection	2021-01-27
201810-0910-003 Approved without change	Extension without change of a currently approved collection	2018-12-06
201507-0910-001 Approved without change	Extension without change of a currently approved collection	2015-07-08
201206-0910-004 Approved without change	New collection (Request for a new OMB Control Number)	2012-06-08

OMB Details

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

Federal Enterprise Architecture: Health - Consumer Health and Safety