Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products-Questions and Answers; Draft Guidance for Industry; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products--Questions and Answers." FDA is issuing this guidance to provide manufacturers, packers, distributors, and their representatives (firms) with information to consider when developing FDA-regulated promotional labeling and advertisements (promotional materials) for prescription reference and biosimilar products licensed under the Public Health Service Act (PHS Act). Although the guidance covers promotional issues involving both reference and biosimilar products, some questions and answers are focused on only biosimilar product promotional materials. The guidance does not discuss considerations unique to promotional materials for interchangeable biosimilars.