FDA finalizes Guidance on Promotional Labeling and Advertising for biologicals

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FDA finalizes Guidance on Promotional Labeling and Advertising for biologicals

INICIO/Directrices | Posted 25/05/2026 0 Post your comment

In December 2025, the US Food and Drug Administration (FDA) published ‘Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products Questions and Answers Guidance for Industry’. This is an updated and finalized version of the draft guidance published in 2024 [1].

The document is designed to address industry questions concerning the promotion of biologicals licensed under section 351(a) of the Public Health Service Act (PHS Act), as well as biosimilar and interchangeable biosimilar products licensed under section 351(k) of the PHS Act. The guidance discusses considerations for presenting data and information about reference products or biosimilars—including interchangeable biosimilar products—in promotional communications. Its goal is to help ensure that these communications are presented accurately, truthfully, and without any misleading claims.

This finalized guidance was also published to satisfy a requirement of the Biosimilar User Fee Amendments of 2022 (BsUFA III) for new guidance on promotional labelling and advertising considerations for interchangeable biosimilar products.

The document is presented in question-and-answer format and outlines the following:

General requirements for the content of FDA-regulated promotional communications for reference products and biosimilars
How companies should identify reference products and biosimilars in promotional communications
What companies should consider when developing promotional communications for a biosimilar product:
- Presenting information from the studies conducted to support licensure of the reference product when the information is included in the FDA-approved labelling of both the reference product and the biosimilar
- Presenting data or information related to the safety or effectiveness of the biosimilar that is not included in the FDA-approved labelling for that product
- Considerations for companies when comparing a biosimilar and its reference product in promotional communications
- Additional considerations for companies when developing promotional communications for reference products or biosimilars.

As with the 2024 draft guidance, the document also outlines examples of how to apply these considerations to promotional communications.

Key changes from the 2024 draft guidance to the final guidance include:

Clarification that the recommendations in the guidance apply regardless of the medium of communication, e.g., paper, digital
Expanded discussion on considerations that firms should take into account when comparing biosimilar products and reference products

Interestingly, in December 2025, the Organisation for Economic Co-operation and Development (OECD) published a working paper whose findings indicate that while promotional regulation plays a role, comprehensive policy frameworks are necessary to support the adoption of biosimilars [2].

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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA Guidance on Promotional Labelling and Advertising for Biologicals, Biosimilars and Interchangeables [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 May 25]. Available from: www.gabionline.net/guidelines/fda-guidance-on-promotional-labelling-and-advertising-for-biologicals-biosimilars-and-interchangeables
2. GaBI Online - Generics and Biosimilars Initiative. OECD study finds no direct link between advertising rules and biosimilar uptake [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 May 25]. Available from: www .gabionline.net/biosimilars/research/oecd-study-finds-no-direct-link-between-advertising-rules-and-biosimilar-uptake

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Source: US FDA