In April 2024, the U.S. Food and Drug Administration (“FDA”) issued revised draft guidance, “Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers,” (the “Draft Guidance”) intended to address common questions that arise during the process of developing promotional communications for prescription reference products and biosimilar products, including interchangeable biosimilar products licensed under the Public Health Service Act (the “PHS Act”).
More specifically, the revised Draft Guidance outlines considerations for presenting data and information about such products in promotional communications to ensure they are truthful, non‑misleading and accurate—standards that apply to the advertising and promotion of all prescription drugs.
Background
The FDA issued an initial draft guidance in February 2020 for developing FDA-regulated promotional labeling and advertising for prescription reference products and biosimilars in anticipation of an increased number of licensed products and consequently, a potential increase in promotion. A biosimilar is a medication made from natural or living sources, that is highly similar to the reference biologic product. The term biosimilar product refers to a product that is licensed under section 351(k) of the PHS Act as biosimilar to or biosimilar to and interchangeable with a reference product. On the other hand, a reference product is a single biological product licensed under section 351(a) of the PHS Act against which a biological product is evaluated in a 351(k) application (section 351(i)(4) of the PHS Act (42 U.S.C. 262(i)(4))).
A biosimilar and its reference product are made from the same types of sources and offer the same treatment risks and benefits. Despite similarities, biosimilars are not identical to their reference product due to minor differences in clinically inactive components for which there are no clinically meaningful differences in terms of safety, purity, or potency. Biosimilar products require FDA approval to be deemed interchangeable with its reference biologic, as they are not automatically interchangeable upon initial approval.
Highlights from the Revised Draft Guidance
The major differences between the initial 2020 draft guidance and the revised Draft Guidance are the inclusion of additional recommendations, a new example of a misleading promotional communication for interchangeable biosimilar products, guidance on post-marketing reporting requirements and editorial updates for reader clarity.
Data Not Included in FDA-Approved Labeling of the Biosimilar Product
When developing promotional communications that include data or information related to the safety or effectiveness of a biosimilar product that is not included in the product’s FDA-approved labeling (e.g., studies that supported the demonstration of biosimilarity between the biosimilar product and the reference product are generally not included), the FDA recommends that any communications be consistent with the principles outlined in the guidance for industry titled, “Medical Product Communications That Are Consistent With the FDA-Required Labeling: Questions and Answers,” and also satisfy “applicable statutory and regulatory requirements.”
New Example of Misleading Promotional Communication
To emphasize the importance of avoiding comparative efficacy or safety claims in promotional materials, the FDA provides a new example of a misleading promotional communication for interchangeable biosimilar products. In the example (Question 7, example 4), the FDA explains that it is misleading for a product that is licensed as an interchangeable biosimilar to suggest in its promotional materials that it is superior in safety and effectiveness to a non-interchangeable biosimilar simply because the product has been approved as interchangeable.
Further, comparing the number of indications for which a product is licensed to support claims about its safety or efficacy would be considered misleading if it creates an overall impression that the biosimilar product is less safe or effective than the reference product just “because the biosimilar product is licensed for fewer indication than the reference product.”
Postmarketing Reporting Requirements
The FDA clarifies that postmarketing reporting requirements for submitting promotional communications to the FDA do apply to promotional communications for reference products and biosimilar products. Specifically, the FDA states that “specimens of mailing pieces and any other labeling or advertising devised for promotion of the reference product or biosimilar product must be submitted to FDA at the time of initial dissemination of the labeling or at the time of initial publication of the advertisement, as applicable, and must be accompanied by a completed Form FDA 2253.”
Practical Takeaways
- Avoid making comparisons in promotional communications as these can easily be considered misleading.
- When appropriate, consider voluntarily requesting feedback from the FDA on proposed advertising or communication before dissemination. This can be a useful tool to ensure that the advertising is consistent with the FDA’s guidance. That said, organizations should keep in mind that once the FDA provides feedback on a piece, the company must follow the recommendation for the particular piece and any future communications with the same content.
- Ensure that all marketing materials are reviewed by the Promotional Review Committee before submission to the FDA to ensure compliance with all applicable regulatory requirements.
For more information on the advertising and promotion of drugs, biologics or medical devices, please contact:
- Carolina Wirth at (202) 780-2989 or cwirth@hallrender.com;
- Jemalyn Harvey at (202) 780-2990 or jharvey@hallrender.com; or
- Your primary Hall Render contact.
Special thanks to Tarra Olfat, Summer Associate, for her assistance with the preparation of this article.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.
