On December 9, 2025, the US Food and Drug Administration (FDA) finalized guidance on promotional labeling and advertising for biologics, biosimilars, and interchangeable biosimilars. The guidance aims to ensure that promotional materials are accurate, truthful, and not misleading. It also gives industry clearer direction on FDA’s expectations.
The guidance applies to biologics approved under section 351(a) of the Public Health Service (PHS) Act, as well as biosimilar and interchangeable biosimilar products approved under section 351(k). It also meets a requirement under the Biosimilar User Fee Amendments of 2022 (BsUFA III) to address promotional issues related to interchangeable biosimilars.
What’s Included in the Final Guidance
The guidance is organized in a question-and-answer format and covers several key topics, including:
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General requirements for promotional content
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How to identify reference products and biosimilars in promotional materials
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When and how to use data from studies that supported approval of the reference product
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Considerations for comparing biosimilars to their reference products
FDA also includes examples of promotional presentations it considers acceptable.
Key Updates From the April 2024 Draft
The final guidance makes only minor changes, but two clarifications stand out:
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FDA confirms that the recommendations apply to all communication formats, including print and digital channels.
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Updated language in Question 5 highlights the risk of misleading comparative claims. This is especially important when differences in approved indications could suggest that a biosimilar is less safe or less effective than its reference product.
FDA also stresses that whether a promotional claim is misleading depends on the full context. The overall message matters—not just technical accuracy.
What This Means for Manufacturers
As competition in the biosimilar market increases, manufacturers should closely review how they present promotional claims. This is particularly important for comparative messaging and digital content. Strong coordination across regulatory, legal, and commercial teams helps ensure materials meet FDA expectations and reduces enforcement risk.
How We Can Help
FDA promotional requirements for biologics and biosimilars can be difficult to navigate, especially as guidance changes and new channels emerge. We help life sciences companies manage regulatory data, labeling, and promotional content with confidence. Get in touch with us to see how we can help you.