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# Guide on Biosimilar Prescribing Information
- URL: https://www.fdaweb.com/guide-on-biosimilar-prescribing-information/
- Published: 2018-07-19T12:00:00.000Z
- Updated: 2026-09-15T00:20:36.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141914

*Federal Register* notice: FDA has made available a final guidance entitled “Labeling for Biosimilar Products.” The document provides recommendations on the prescribing information (package insert), except for certain recommendations pertaining to FDA- approved patient labeling (e.g., Patient Information, Medication Guide, and Instructions for Use). It also provides an overview of FDA’s recommendations for labeling for biosimilar products. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-07-19/pdf/2018-15391.pdf?ref=fdaweb.com).