FDA finalizes guidance on biologic, biosimilar promotional labeling
The US Food and Drug Administration (FDA) has finalized guidance on promotional labeling and advertising for prescription biosimilars, interchangeable biosimilar products, and their reference listed drugs (RLDs) to ensure that such labeling is accurate and truthful.The document is designed to address industry questions concerning the promotion of biologics approved under section 351(a) of the Public Health Service Act (PHS Act), as well as biosimilar and interchangeable biosimilar products approved under section 351(k) of the PHS Act. Its purpose is to ensure that data and information about these products are presented accurately, truthfully, and without any misleading claims in promotional communications.
It was also published to satisfy a requirement of the Biosimilar User Fee Amendments of 2022 (BsUFA III) for new guidance on promotional labeling and advertising considerations for interchangeable biosimilar products.
This guidance finalizes the revised draft issued on 25 April 2024, with some minor revisions. (RELATED: FDA updates guidance on promotional labeling and advertising of biosimilars, Regulatory Focus 26 April 2024).
Most of the guidance is presented in a question-and-answer format. The questions address several key topics, including: the general requirements for the content of promotional communications regarding reference and biosimilar products; how firms should identify reference products and biosimilar products in their promotional materials; what firms should consider when presenting information from studies that support the licensure of the reference product, especially if that information is included in the FDA-approved labeling for both the reference product and the biosimilar; and what firms should take into account when comparing a biosimilar product to its reference product in their promotional communications.
The guidance also includes examples to illustrate situations where FDA would approve the promotional communications.
Changes from the April 2024 draft guidance include a clarification in the introduction section stating that the recommendations in the guidance apply “regardless of the medium of communication (e.g., paper, digital).”
Additional text in Question 5 discusses considerations for firms comparing biosimilar and reference products.
The added text states that, “While a determination of whether any presentation is misleading is necessarily fact specific, FDA recommends that firms consider this possibility carefully when developing their promotional communications. For example, FDA recommends that firms avoid presentations in promotional communications for a reference product that compare the number of indications for which the reference product is licensed to the number of indications for which the biosimilar product is licensed in a manner that creates the overall impression that the biosimilar product is less safe or less effective than the reference product because the biosimilar product is licensed for fewer indications than the reference product.”
Final guidance
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