The United States Food and Drug Administration (FDA) recently published revised guidance on promotional labeling and advertising for prescription biosimilar drugs and their reference products. The draft guidance, Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry, intends to answer industry questions about developing FDA-regulated promotional communications for prescription reference products or prescription biosimilar products, including interchangeable biosimilar products and also serves to satisfy a requirement of the Biosimilar User Fee Amendments of 2022 (BsUFA III) for new guidance.
The revised draft guidance discusses considerations for presenting data and information about reference products or biosimilar products in these promotional communications to help ensure that they are accurate, truthful, and non-misleading. The revised draft guidance also includes information about general requirements for the content of FDA-regulated promotional communications that apply to reference products and biosimilar products as well as more specific considerations for developing promotional communications for reference products and biosimilar products.
This draft guidance replaces the 2020 draft guidance, Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products: Questions and Answers. The updated draft includes additional recommendations and an example of application for interchangeable biosimilar products. In writing the draft guidance, the FDA considered comments received on the 2020 draft guidance and expanded the scope of the guidance to fulfill the aforementioned requirement under BsUFA III.
Within the guidance, FDA notes that biosimilarity means a biological product is highly similar to the reference product, but that there may be minor differences in clinically inactive components. To meet the standard for interchangeability (where a product can be exchanged without involving the prescriber), an applicant must demonstrate biosimilarity and prove that the biologic has the same clinical results as the reference product in any given patient without greater safety risks or diminished efficacy.
Additionally, the guidance states that the quality and compliance of promotional communications is based on how information is presented, the type and quality of data included, and how disclosures are handled. Promotional references to studies of biosimilars should reflect FDA-approved labeling for the biosimilar products. “FDA regulations also require that applicants promptly revise promotional labeling and advertising for their biological products upon certain changes to the FDA-approved labeling, including changes to risk information in the FDA-approved labeling.”
FDA also indicated that applicants should be wary when comparing reference products and biosimilars as there may be variations in safety and efficacy results in studies aimed at proving biosimilarity, but that does not mean they are clinically meaningful. “In some cases, presenting otherwise accurate information about a reference product or about a biosimilar product could contribute to a misleading presentation when provided in a comparative context.”
The draft guidance also confirms that firms that are voluntarily seeking feedback from the FDA on promotional communications for reference products or biosimilar products prior to the dissemination of the communications should continue to follow the current process for submitting draft promotional communications for comment.
The draft guidance does not make any recommendations for non-prescription products.
The FDA is seeking comments on the draft guidance. Comments must be submitted by June 24, 2024.