FDA Updates Draft Guidance on Promotional Communications of Prescription Biologics and Biosimilars

On April 25, 2024, the FDA published a notice of availability in the Federal Register for its revised draft guidance, entitled “Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers.”

The purpose of the revised draft guidance is to address questions that manufacturers, packers, distributors, and their representatives may have when developing FDA-regulated promotional labeling and advertising communications for prescription reference drugs and their biosimilars and interchangeable biosimilars licensed under the Public Health Service Act.

The updated guidance includes information on the general requirements for the content of FDA-regulated promotional communications about reference or biosimilar products and provides some examples to illustrate the FDA’s current recommendations for addressing reference, biosimilar, and interchangeable biosimilar products in product promotion.  The guidance remains in draft form and, as with any FDA guidance document, it is not legally binding and, when final, will reflect FDA’s “current thinking” on this topic.

Topics the FDA addresses include correctly identifying products, presenting comparative study data, and avoiding any suggestion that a biosimilar product may be less safe or effective, to highlight a few.

Notably, the importance of truthful, non-misleading promotional practices is a recurring theme.

The 60-day comment period for this revised draft guidance ends on 6/24/2024.

Instructions for submitting comments to this guidance can be found here.

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