Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers Guidance for Industry December 2025

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/promotional-labeling-and-advertising-considerations-prescription-biological-reference-products?utm_medium=email&utm_source=govdelivery Today, the U.S. Food and Drug Administration issued the final guidance, “Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers.” This guidance addresses questions that manufacturers, packers, distributers, and their representatives may have when developing FDA-regulated promotional communications for prescription biological reference products and biosimilar products, including interchangeable biosimilar products, to help ensure that these promotional communications are accurate, truthful, and non-misleading. FDA remains committed to supporting adoption of biosimilars and identifying false or misleading statements about biological products. The guidance issued today finalizes the April 2024 revised draft guidance of the same title and fulfills the BsUFA III commitment for final guidance on this topic.