USFDA Q&A: Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products
- Sharan Murugan
- 35 minutes ago
- 4 min read
As biosimilars and interchangeable biosimilars become an integral part of modern biologic therapy, promotional communications around these products require heightened regulatory care. To address recurring industry questions and reduce the risk of misleading claims, the FDA has issued the guidance Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products.
Published in 12 December 2025, this Questions and Answers (Q&A) guidance reflects FDA’s current thinking on how firms should develop promotional labeling and advertisements that are accurate, balanced, and non-misleading when discussing reference biologics, biosimilars, and interchangeable biosimilars.
This guidance is intended to help firms navigate these complexities by explaining how to present data and information in a manner that reflects FDA’s determinations on biosimilarity, interchangeability, safety, and effectiveness, without creating inaccurate impressions.
A reference product is the single biological product licensed under section 351(a) of the Public Health Service (PHS) Act against which a biosimilar is evaluated.
A biosimilar product is a biological product licensed under section 351(k) of the PHS Act that is highly similar to the reference product, notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences in safety, purity, or potency.
An interchangeable biosimilar product meets the biosimilarity standard and, in addition, is expected to produce the same clinical result in any given patient.
Q1: General Requirements for Promotional Communications
FDA reiterates that promotional labeling and advertising for biological products must be truthful, non-misleading, and balanced. Communications must fairly present both benefits and risks and disclose material facts necessary to avoid misinterpretation.
Whether a communication is misleading depends on a fact-specific analysis, including how information is presented, the quality of supporting data, express or implied claims, and the surrounding context. FDA also expects firms to promptly update promotional materials when FDA-approved labeling changes, particularly when risk information is revised.
Q2: Correct Identification of Products
FDA places strong emphasis on clear and specific product identification. Promotional communications must accurately identify whether information refers to a reference product, a biosimilar product, or an interchangeable biosimilar product.
The guidance explains the importance of correctly using:
the proprietary name (brand name),
the proper name (FDA-designated nonproprietary name), and
the core name, which is shared among related biologics.
Accurate identification prevents data or claims from being incorrectly attributed to the wrong product and helps healthcare professionals clearly understand which product is being discussed.
Q3: Use of Reference Product Study Data in Biosimilar Promotion
When promoting a biosimilar product, firms may reference data from studies conducted to support licensure of the reference product only to the extent that such data appear in the biosimilar’s FDA-approved labeling.
FDA explains that biosimilar labeling generally incorporates relevant data from the reference product’s labeling—such as clinical studies, pharmacology, immunogenicity, and toxicity—limited to the conditions of use for which the biosimilar is licensed. Promotional communications should therefore rely on the biosimilar’s approved labeling rather than directly citing the reference product’s original studies.
Q4: Presenting Data Not Included in Approved Labeling
Firms may wish to present additional data, such as studies supporting biosimilarity, that are not included in FDA-approved labeling. FDA states that such communications must follow the principles outlined in its guidance on communications consistent with FDA-required labeling.
Any such presentation must be supported by appropriate scientific evidence, clearly contextualised, and compliant with all statutory and regulatory requirements. Failure to provide adequate context may result in misleading impressions.
Q5: Comparative Claims Between Biosimilars and Reference Products
FDA cautions strongly against comparative presentations that imply clinically meaningful differences between a biosimilar and its reference product. Because FDA has already determined that no such differences exist, claims suggesting superiority or inferiority are likely to be false or misleading.
Even accurate numerical differences—such as small variations in response rates or adverse event frequencies—can become misleading if they lack appropriate statistical and clinical context. FDA advises firms to carefully evaluate whether comparisons could inadvertently imply differences in safety, purity, or potency.
Q6: Additional Promotional Considerations
The guidance further explains that promotional communications should not:
imply that a biosimilar is less safe or effective because it is not interchangeable,
suggest that patients should avoid biosimilars unless substitution is permitted,
or claim that biosimilarity means the products are identical.
FDA reminds firms that batch-to-batch variability is normal for all biologics, including reference products, and does not imply reduced safety or effectiveness. Promotional materials should reflect this scientific reality.
Q7: Practical Examples of Acceptable and Misleading Promotions
FDA provides multiple hypothetical examples illustrating how promotional claims may or may not comply with regulatory expectations. These examples show that:
Claims supported by labeling and contextualised data are generally acceptable.
Selective presentation of numerical differences without clinical relevance is misleading.
Implying superiority based on interchangeability status is inappropriate.
These scenarios reinforce the importance of context, balance, and scientific accuracy in promotional communications.
Q8 and Q9: FDA Review and Postmarketing Requirements
Firms may voluntarily submit draft promotional materials to FDA for review before dissemination. Once materials are disseminated, postmarketing submission requirements apply. Promotional labeling and advertisements must be submitted to FDA with Form FDA 2253 at the time of initial use or publication.
These requirements apply equally to reference products, biosimilars, and interchangeable biosimilars.