BRIEF—FDA final guidance on promotional labeling and advertising for biosimilars

The US Food and Drug Administration (FDA) yesterday 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.

The FDA said it remains committed to supporting adoption of biosimilars and identifying false or misleading statements about biological products.