FDA Guidance on Promotional Labeling for Biosimilar Products

Detected February 6th, 2026

Summary

The FDA has issued new guidance addressing promotional labeling and advertising considerations for prescription reference products, biosimilar products, and interchangeable biosimilar products. The guidance aims to ensure promotional communications are accurate, truthful, and non-misleading for manufacturers and their representatives.

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What changed

The FDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research have released guidance (Docket Number: FDA-2019-D-5473) concerning promotional labeling and advertising for prescription reference products, biosimilar products, and interchangeable biosimilar products. This guidance provides considerations for firms on how to present data and information in promotional communications to ensure accuracy and prevent misleading claims.

Manufacturers, packers, distributors, and their representatives involved with these products should review the guidance to ensure their promotional materials comply with FDA regulations. While the guidance is non-binding, adherence is crucial for maintaining compliance and avoiding potential enforcement actions related to false or misleading advertising. Comments on the guidance can be submitted at any time.

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Guidance Documents

Docket Number: FDA-2019-D-5473 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance addresses questions that manufacturers, packers, distributors, and their representatives (firms) may have when developing FDA-regulated promotional labeling and advertisements (promotional communications) for prescription reference products, biosimilar products, and interchangeable biosimilar products licensed under the Public Health Service Act. The guidance discusses considerations for presenting data and information about reference products or biosimilar products in promotional communications to help ensure that they are accurate, truthful, and non-misleading.