Promotional Labeling is the Target of New Q&A Document on Biosimilars and Reference Products

Today, the FDA released a guidance document titled Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products: Questions and Answers (here).  The document provides the FDA’s responses to eight questions designed to help firms assure that they do not run afoul in advertising or promotion when describing similarities and differences between the products (e.g., the biosimilar is licensed for fewer than all indications or routes of administration than the reference product).

It appears that the FDA is advancing its position (as well as the Association of Accessible Medicines’) that there is a rash of potentially misleading information about biosimilars floating around in the industry.  FDA appears to want to reinforce that “[A] biosimilar is a biological product that is highly similar to the reference product notwithstanding minor differences in clinically inactive components and for which there are no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, or potency.”  In addition, the guidance states the FDA statutory and regulatory position that “[O]nce FDA licenses a biosimilar or interchangeable product, providers and patients can be assured of the safety and effectiveness of a biosimilar or an interchangeable product, just as they would be for the reference product.”

The Q&A document provides advice on, among other things,  how reference and biosimilar products should be addressed in labeling and promotional materials; what information a biosimilar can include in its labeling when it is approved for fewer indications than the reference product; what information a firm could present in promotional material about the data generated to support the finding of “being highly similar to the reference product” and clearly states that that information should not appear in the labeling of the biosimilar product.  It also includes a few hypothetical examples of correct approaches and approaches that could be considered violative.