The FDA has released updated recommendations on promotional labeling and advertising for biologics, biosimilars, and interchangeable biosimilars. These clarifications are intended to support consistent, compliant communication practices across the sector. Stakeholders involved in regulatory affairs, medical affairs, and commercial operations will find the document particularly relevant.
The U.S. Food and Drug Administration’s guidance, Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilars, provides an updated, consolidated framework describing how firms should approach the development, review, and dissemination of promotional materials for biological products licensed under sections 351(a) and 351(k) of the Public Health Service Act. The guidance reiterates principles already embedded in the Federal Food, Drug, and Cosmetic Act, particularly the statutory requirements related to misbranding and fair balance.
Consistent with longstanding FDA policy, the guidance underscores that promotional communications must be truthful, non-misleading, and appropriately balanced with respect to benefits and risks. The agency highlights that omission of material facts, selective excerpting of data, disproportionate emphasis on favorable findings, or suboptimal presentation of risk information may render a communication misleading. The guidance acknowledges that context, including formatting, graphical elements, and overall message structure, can influence whether a communication meets the statutory standard.
A significant portion of the document addresses accurate product identification, particularly distinguishing between reference products, biosimilars, and interchangeable biosimilars. Because biologics often share core names and have similar proper names, the FDA advises firms to refer to products using the appropriate proprietary name or proper name to avoid ambiguity. This is intended to minimize confusion among prescribers and patients and to ensure the promoted product is clearly understood in the context of its licensure pathway.
The guidance provides additional clarity regarding the use of reference product clinical data in biosimilar promotional materials. While biosimilars rely on comparative studies for licensure, the FDA states that any presentation of such data must be consistent with the biosimilar’s own FDA-approved labeling, rather than the labeling of the reference product. The agency cautions that extrapolating findings, overstating clinical implications, or implying a difference in safety or efficacy when none has been demonstrated may result in misleading claims.
The document further addresses comparative statements, noting that firms should avoid implying that either a reference product or a biosimilar is clinically superior or inferior without substantial evidence. Minor manufacturing differences or routine analytical variability should not be framed as clinically meaningful distinctions. Comparative claims, if used, must reflect the scientific and regulatory basis on which the products were approved.
The FDA’s updated guidance offers a structured, methodical clarification of expectations surrounding promotional practices for biologics and biosimilars. Organizations responsible for reviewing commercial materials will likely need to align internal procedures with these recommendations to ensure compliance. As the biologics market expands, adherence to these principles will support accurate communication and regulatory consistency across the industry.
