In December 2025, the U.S. Food and Drug Administration (FDA) released an updated guidance document addressing promotional labeling and advertising considerations for prescription biological reference products, biosimilar products, and interchangeable biosimilar products. Issued under the auspices of the U.S. Department of Health and Human Services, the guidance reflects the Agency’s current thinking on how firms should develop truthful, accurate, and non-misleading promotional communications for these products.
The document, prepared by the Center for Drug Evaluation and Research (Center for Drug Evaluation and Research) in collaboration with the Center for Biologics Evaluation and Research (Center for Biologics Evaluation and Research), is presented in a question-and-answer format and contains nonbinding recommendations for industry stakeholders.
Regulatory Context
Biological products licensed under section 351(a) of the Public Health Service (PHS) Act serve as reference products for biosimilar and interchangeable biosimilar products licensed under section 351(k). The biosimilar licensure pathway allows for abbreviated approval based on a demonstration that a product is highly similar to its reference product and that there are no clinically meaningful differences in safety, purity, or potency.
To qualify as interchangeable, a biosimilar must additionally demonstrate that it can be expected to produce the same clinical result as the reference product in any given patient and that switching between products does not increase risk. These statutory distinctions underpin many of the promotional considerations discussed in the guidance.
Scope and Purpose of the Guidance
The guidance addresses questions firms may have when developing FDA-regulated promotional labeling and advertisements for prescription biological products. It applies to communications across all media formats, including print and digital platforms, and focuses on ensuring that promotional content remains accurate, balanced, and not misleading.
While the guidance does not establish legally enforceable requirements, it outlines FDA’s recommendations for complying with existing statutory and regulatory provisions under the Federal Food, Drug, and Cosmetic Act and its implementing regulations.
Key Principles for Promotional Communications
FDA emphasizes that promotional communications for reference products and biosimilar products must:
- Be truthful and non-misleading regarding safety and effectiveness
- Present benefits and risks in a balanced manner
- Disclose material facts necessary for an accurate understanding of the product.
Determinations of whether a communication is misleading are fact-specific and depend on factors such as data quality, presentation context, express and implied claims, and the adequacy of disclosures.
Product Identification and Nomenclature
A central theme of the guidance is the importance of clearly and correctly identifying biological products in promotional materials. FDA notes that biological products may be referred to by proprietary (brand) names, proper names, and core names. Accurate use of these identifiers helps prevent misattribution of data and ensures that audiences understand which product is being discussed.
The guidance highlights that when risks or data apply to both a biosimilar and its reference product, consistent nomenclature may be appropriate to reflect that shared applicability.
Use of Clinical Data in Promotion
When promotional communications for biosimilar products reference clinical data originally generated to support licensure of the reference product, firms are advised to rely on the biosimilar product’s FDA-approved labeling. Such labeling typically incorporates relevant data from the reference product that support the approved conditions of use for the biosimilar.
The guidance also addresses situations in which firms may wish to present additional safety or effectiveness information not included in FDA-approved labeling, such as data from studies supporting a demonstration of biosimilarity. In these cases, communications should be consistent with FDA policies on medical product communications and supported by appropriate scientific context and disclosures.
Comparative Claims and Misleading Impressions
FDA cautions against promotional presentations that suggest clinically meaningful differences between a reference product and a licensed biosimilar. Claims or implications that one product is safer or more effective than the other, when such differences have not been established, are likely to be considered misleading.
The guidance provides illustrative examples demonstrating how selective presentation of numerical differences, lack of statistical context, or emphasis on licensure pathways can create inaccurate impressions regarding comparative safety or efficacy.
Interchangeability Considerations
For interchangeable biosimilars, FDA underscores that promotional communications should not imply superiority over non-interchangeable biosimilars or reference products based solely on interchangeability status. Similarly, firms should avoid suggesting that non-interchangeable biosimilars are less safe or effective because they do not carry an interchangeability designation.
Review and Reporting Processes
The guidance outlines existing mechanisms for firms that wish to voluntarily seek FDA feedback on draft promotional materials prior to dissemination. It also reiterates postmarketing reporting requirements, including the submission of promotional materials to FDA at the time of initial dissemination, accompanied by the appropriate regulatory forms.
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Written by Nare Hovhannisyan, MD