> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Draft Biosimilar Licensure Guidance
- URL: https://www.fdaweb.com/fda-draft-biosimilar-licensure-guidance/
- Published: 2020-02-06T12:00:00.000Z
- Updated: 2026-09-14T16:02:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146028

FDA has published a draft guidance, *Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed*, with recommendations for applicants seeking licensure under section 351(k) of the Public Health Service Act of a proposed biosimilar or interchangeable biosimilar for fewer than all of the reference product’s licensed conditions of use. The [document](https://www.fda.gov/media/134932/download?ref=fdaweb.com) also gives recommendations on the submission of a licensed 351(k) BLA seeking to add a condition of use that previously has been licensed for the reference product to the labeling of a licensed biosimilar or interchangeable product, including considerations related to the timing of such submissions.

The guidance includes recommendations on these specific issues:

- submission of an application seeking licensure of a proposed biosimilar or proposed interchangeable biosimilar for fewer than all of the reference product’s licensed conditions of use;
- development of proposed labeling when the applicant seeks licensure of a proposed biosimilar or proposed interchangeable product for fewer than all of the reference product’s licensed conditions of use;
- submission of a supplement to an application for a biosimilar or interchangeable biosimilar to seek licensure for a condition of use previously licensed for the reference product; and
- timing for the submission of a 351(k) BLA or supplement with the goal of obtaining licensure of a condition of use for a biosimilar or interchangeable product as soon as possible after the expiration of any relevant exclusivity or patents.