FDA Finalizes Guidance on Promotional Labeling for Biologics and Biosimilars: The US Food and Drug Administration (FDA) has finalized new guidance on promotional labeling and advertising for prescription biosimilars, interchangeable biosimilars, and their reference listed drugs (RLDs). The updated document aims to ensure that promotional materials remain accurate, truthful, and not misleading, supporting patient safety and informed decision-making.
Guidance Clarifies Industry Expectations
The finalized guidance addresses long-standing industry questions surrounding promotion of biologics approved under section 351(a) of the Public Health Service (PHS) Act and biosimilars approved under section 351(k). The updated framework explicitly emphasizes that communications must present data responsibly and avoid creating an incorrect impression of relative safety or effectiveness.
Importantly, this guidance fulfills a requirement of the Biosimilar User Fee Amendments of 2022 (BsUFA III), which mandates new direction on promotional labeling and advertising considerations for interchangeable biosimilar products.
Builds on 2024 draft with revisions
This final version reflects minor changes since the revised draft issued on 25 April 2024. Most of the document is structured in a question-and-answer format to help firms navigate promotional standards clearly.
The questions cover key areas such as:
- Identifying reference products and biosimilar products in promotional communications
- Requirements for presenting study data that supports licensure
- How firms may compare biosimilars with reference drugs
- Preventing misleading impressions in comparative marketing
The FDA also included examples illustrating compliant communications, helping companies apply the guidance in real-world situations.
Clarifications Added
Among the updates, the FDA clarified that the guidance applies “regardless of the medium of communication (e.g., paper, digital)”—ensuring equal compliance expectations across platforms.
Additionally, Question 5 now includes expanded language urging care when firms compare the number of indications between reference and biosimilar products. The FDA cautions against creating the impression that a biosimilar is “less safe or less effective” simply because it may have fewer licensed indications.
Ensuring Accuracy Builds Trust
By finalizing this guidance, FDA reinforces a core message: the credibility of biosimilar adoption depends on clear, precise, and scientifically grounded communication. As the US market for biologics and biosimilars grows, these promotional standards are expected to support both regulatory integrity and public confidence.
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