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# Draft Guide on sBLA for Biosimilar Use
- URL: https://www.fdaweb.com/draft-guide-on-sbla-for-biosimilar-use/
- Published: 2020-02-07T12:00:00.000Z
- Updated: 2026-09-14T16:02:16.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5146042

*Federal Register* notice: FDA has announced a draft guidance entitled “Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed.” The document provides recommendations on submitting a BLA supplement 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. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-02-07/pdf/2020-02421.pdf?ref=fdaweb.com).