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USFDA Guidance: Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Q&A

On 24 April 2026 (Wednesday) the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research released a revised draft guidance for "Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers".

Biosimilarity means “that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components” and that “there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product”.

The revised draft guidance addresses questions firms may have when developing FDA-regulated promotional labels and advertisements (promotional communications) for prescription reference products and prescription biosimilars, including interchangeable biosimilars.

This guidance discusses considerations for presenting data and information about reference products or biosimilar products in these promotional communications to help ensure that they are accurate, truthful, and non-misleading.

Interchangeable biosimilar products may be substituted for the reference 61 product without the intervention of the prescribing health care provider (HCP). Once FDA licenses a biosimilar product, including an interchangeable biosimilar product, HCPs and patients can be confident of the safety and effectiveness of the biosimilar product, just as they would be for the reference product.

FDA regulations also require that applicants promptly revise promotional labeling and advertising for their biological products upon certain changes to the FDA-approved labeling, including changes to risk information in the FDA-approved labeling.

Promotional communications about a product’s licensure as biosimilar to a reference product should be accurate. When multiple products are licensed as biosimilar to and interchangeable with or biosimilar to but not interchangeable with the same reference product, promotional communications should avoid representing or suggesting that any of these products are less safe or effective than each other for their approved uses based on their licensure pathways.

Check out this guidance for more detailed information on the questions and answers.


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