The US Food and Drug Administration has issued its final guidance outlining expectations for promotional labeling and advertising for biologics, biosimilars, and interchangeable biosimilars. The document aims to ensure that promotional communications across all media are accurate, non-misleading, and consistent with the approved product labeling.
This final version fulfills a commitment under BsUFA III and builds on the draft guidance issued in April 2024, providing additional clarity for manufacturers navigating promotional compliance for products licensed under sections 351(a) and 351(k) of the Public Health Service Act.
A Clarified Framework for Promotional Communications
The guidance uses a Q&A structure to address long-standing industry questions related to:
• Content requirements for communications about reference biologics and biosimilar products
• Proper identification of reference products versus biosimilars in promotional materials
• Use of clinical and analytical data that supported licensure of the reference product
• Comparisons between a biosimilar and its reference product in promotional claims
• Presentation of data across digital and traditional media
One notable addition is the explicit reminder that the recommendations apply to any promotional medium—including paper, digital platforms, and emerging channels such as social media.
New Clarification: Avoid Misleading Comparisons
A key revision in the final guidance expands on how firms should present comparisons between a biosimilar and its reference product. FDA cautions against promotional messaging that implies a biosimilar is less safe or effective simply because it is licensed for fewer indications.
This scenario often arises when a biosimilar manufacturer has not sought approval for every indication held by the reference product, typically due to patent limitations—not because of clinical inferiority.
FDA emphasizes that such comparisons may mislead patients and providers if they suggest an unsupported difference in performance or safety.
Promotional Accuracy Remains the Core Expectation
Although most of the guidance aligns closely with earlier versions, the final document reinforces FDA’s longstanding position: promotional communications must reflect the totality of scientific evidence and avoid overstating distinctions between products.
Manufacturers are expected to:
- Ensure all promotional claims are consistent with FDA-approved labeling
- Avoid implying superiority or reduced effectiveness without adequate data
- Present study data in a fair, balanced, and scientifically grounded manner
- Clearly identify whether information relates to the reference product or the biosimilar product
The guidance also contains multiple examples illustrating compliant and non-compliant promotional scenarios.
What This Means for Manufacturers
With biosimilar competition expanding across therapeutic areas, promotional strategy remains a key focus for both innovators and biosimilar sponsors. This guidance reinforces critical principles for compliant communication and minimizes the risk of promotional enforcement actions.
Companies should ensure cross-functional alignment—spanning regulatory, legal, medical affairs, and marketing—to review and adjust promotional materials accordingly.
As the biosimilar market continues to mature, transparent, data-driven communication will play an essential role in building confidence among prescribers, payers, and patients.
At EMMA International
EMMA International supports biologic and biosimilar manufacturers with regulatory strategy, promotional compliance review, quality system alignment, and risk-based approaches to product lifecycle management. Our experts help ensure that communications remain compliant with current FDA expectations while supporting effective market engagement.
For more information on how EMMA International can assist, visit www.emmainternational.com or contact us at (248) 987-4497 or info@emmainternational.com.
Reference:
U.S. Food and Drug Administration. (2025). Promotional Labeling and Advertising for Biologics, Biosimilars, and Interchangeable Biosimilars: Final Guidance.
Regulatory Affairs Professionals Society. (2025, December 9). FDA finalizes guidance on biologic, biosimilar promotional labeling.
