Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers; Revised Draft Guidance for Industry; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled "Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers." FDA is issuing this revised draft guidance to address questions that manufacturers, packers, distributors, and their representatives (firms) may have when developing FDA-regulated promotional labeling and advertisements (promotional communications) for prescription reference products, biosimilar products, and interchangeable biosimilar products licensed under the Public Health Service Act (PHS Act). In conjunction with the enactment of the Biosimilar User Fee Amendments of 2022 (BsUFA III), FDA agreed to publish a draft guidance on promotional labeling and advertising considerations for interchangeable biosimilar products, as described in the document titled "Biosimilar Biological Product Reauthorization Performance Goals and Procedures Fiscal Years 2023 through 2027." The revised draft guidance is consistent with this commitment and replaces the draft guidance for industry entitled "Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products: Questions and Answers" issued on February 4, 2020.