FDA recently issued a revised draft guidance titled Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products. This guidance provides specific recommendations for all three classes of products—biologics approved under 351(a) of the Public Health Service Act (PHS Act), and biosimilar products and interchangeable biosimilar products approved under 351(k) of the PHS Act—with respect to meeting FDA’s general accuracy and truthful and non-misleading standards that are applied to advertising and promotion of prescription drug products generally.

The newly issued revised draft replaces a 2020 draft guidance issued by FDA with a similar title. The revised draft, in part, restates previously released draft guidance and also provides some additional newly released guidance for industry.

As background, in approving a biosimilar product, FDA makes a determination of biosimilarity that is described in Section 351(i) of the PHS Act and involves a determination that the proposed biosimilar product is “highly similar” to the approved biological product that it references in its application (the “reference product”), notwithstanding certain “minor differences” between the products, and that there are “no clinically meaningful differences” between the biosimilar and the reference product in terms of safety, purity, or potency.

In addition to providing guidance on how to ensure that references to these various types of products are clear and accurate, especially when promotional materials may refer to a biosimilar product, a related reference product, and/or groups of such products, the draft guidance recommends referring to the FDA-approved labeling for a biosimilar product when considering the scope and kinds of information to include in promotional materials, whether that information relates to studies conducted by the biosimilar applicant directly or not.

With respect to certain other information that sponsors may wish to include in their promotional materials (including data or information developed in support of a finding of biosimilarity that is not otherwise reflected in the FDA-approved labeling), FDA recommends looking to its 2018 guidance titled Medical Product Communications That Are Consistent With the FDA-Required Labeling: Questions and Answers for guidance.

Further, FDA cautions that statements in promotional materials for biological reference products or biosimilar products should not undermine FDA’s finding of biosimilarity, including its finding that the products are “highly similar,” including through comparisons of the products in promotional materials.

Similarly, because FDA expects some “minor differences” between biosimilar products and biological reference products, FDA cautions against suggestions that a biosimilar is less safe or less effective than its reference product simply because it is not identical to the reference product.

Finally, continuing with FDA’s broader theme of considering (and generally narrowing) differences between biosimilar and interchangeable biosimilar products, FDA also cautions against suggestions in promotional materials that a biosimilar (not approved as an interchangeable product) is less safe or less effective than an approved interchangeable biosimilar simply because of that difference in licensure.

Recommendations

Sponsors that are considering developing promotional materials for biological reference products or biosimilar products (including interchangeable biosimilar products) should be mindful of FDA’s recommendations in this and related guidances. As FDA gains more and more experience with biosimilars (including related promotional activity by sponsors), sponsors can expect FDA to continue to fine tune its approach to prescription drug promotion in this space. Interested stakeholders should also comment on this draft guidance, with the comment period scheduled to close on June 25, 2024.