Today, the FDA released a draft guidance titled Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers (here). Try saying that without taking a breath!

This draft is a revision of the initial draft guidance issued on February 4, 2020 (85 FR 6201) (the 2020 draft guidance). The pre-publication Federal Register Notice announcing the revised guidance (here) states, “In revising this guidance, FDA considered comments received on the 2020 draft guidance and expanded the scope of the 2020 draft guidance to fulfill the BsUFA III commitment to publish draft guidance on promotional labeling and advertising considerations for interchangeable biosimilar products. Changes from the 2020 draft guidance include additional recommendations and an example for interchangeable biosimilar products. In addition, editorial changes were made to improve clarity.”

The guidance document reflects what we have seen regarding the FDA’s position on its belief that if a biosimilar is approved by the Agency, “the Agency has determined that the biosimilar product is highly similar to the reference product notwithstanding minor differences in clinically inactive components and that there are no clinically meaningful differences in terms of the safety, purity, and potency of the product.” While the FDA acknowledges that, for a product to be deemed interchangeable, sufficient data must have been presented to support that position, the Agency has taken specific steps to remove interchangeable language when speaking about biosimilars in labeling because, with the current evidence, a biosimilar that has been approved must meet a standard that there “are no clinically meaningful differences in terms of the safety, purity, and potency” of the biosimilar and the reference product. This is reflected in the Q&A document albeit with great dexterity.

There are nine questions presented in the draft guidance, the answers for which include examples to help illustrate the Agency’s position about what is allowed and proper with these products. In reading the guidance document, please remember that it addresses promotional and advertising considerations for biosimilar products and NOT approved product labeling.