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.