USA – FDA updates guidance on promotional labeling and advertising of biosimilars
The US Food and Drug Administration (FDA) has published revised guidance on promotional labeling and advertising for prescription biosimilar drugs and their reference products.
The agency issued the draft guidance – Promotional labeling and advertising considerations for prescription biological reference products, biosimilar products, and interchangeable biosimilar products: Questions and answers – on 24 April and will accept comments through 25 June.
The document was designed to address industry questions about the promotion of reference prescription drugs, biosimilars and interchangeable products licensed under the Public Health Service Act, and to satisfy a requirement of the Biosimilar User Fee Amendments of 2022 (BsUFA III) for new guidance. (RELATED: BsUFA III commitment letter details FDA, industry goals for biosimilars program, Regulatory Focus 21 September 2021). It replaces 2020 draft guidance titled Promotional labeling and advertising considerations for prescription biological reference and biosimilar products: Questions and Answers.
More information on the Regulatory Focus Website.
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vroby (4 octobre 2024). USA – FDA updates guidance on promotional labeling and advertising of biosimilars. ELSIBI. Consulté le 7 octobre 2026 à l’adresse https://doi.org/10.58079/12f6u
