FDA Releases Rules for Biosimilar Product Promotion Guidance
Published Date: 12/10/2025
Notice
Summary
The FDA just released clear rules for companies on how to advertise and label prescription biological drugs, including biosimilars and interchangeable biosimilars. This helps drug makers know what’s allowed when promoting these products, making sure info is honest and easy to understand. The new guidance is official as of December 10, 2025, so affected companies should update their ads soon to avoid any hiccups.
Analyzed Economic Effects
2 provisions identified: 0 benefits, 1 costs, 1 mixed.
New FDA Ad Rules for Biologics
On December 10, 2025, FDA issued final guidance on promotional labeling and advertising for prescription reference biological products, biosimilar products, and interchangeable biosimilar products. The guidance tells firms how to identify products, present study information, present data not in FDA-approved labeling (when consistent with labeling), compare biosimilars and reference products, and submit promotional communications to FDA; the recommendations apply regardless of medium (paper or digital).
Pharmacy Substitution Clarified
The guidance reiterates that an interchangeable biosimilar product may be substituted for the reference product without the prescribing healthcare provider's intervention (section 351(i)(3) of the Public Health Service Act). Decisions about pharmacy-level substitution remain subject to State pharmacy law.
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