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# Guidance on Biosimilar Product Labeling
- URL: https://www.fdaweb.com/guidance-on-biosimilar-product-labeling/
- Published: 2016-04-04T12:00:00.000Z
- Updated: 2026-09-14T20:52:39.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135264

*Federal Register* Notice: FDA is making available a draft guidance for industry entitled *Labeling for Biosimilar Products*. It is intended to assist applicants in developing draft prescription drug labeling for proposed biosimilar products and pertains only to the prescribing information (commonly referred to as the package insert). To download this draft guidance, click here. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-04-04/pdf/2016-07611.pdf?ref=fdaweb.com).