The newly issued revised and finalized “Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers: Guidance for Industry” (here) does not differ much from the previous draft guidance of the same title issued on April 25, 2024 (89 FR 31757).  The final guidance was revised to incorporate comments submitted to the docket regarding the 2024 draft guidance; the changes are as outlined below.

  • Clarification that the recommendations in the guidance apply regardless of the medium of communication (e.g., paper, digital);
  • Further discussion related to the considerations that firms should take into account when comparing biosimilar products and reference products; and
  • Editorial changes for consistency, readability, and clarity in conjunction with the enactment of the Biosimilar User Fee Amendments of 2022.

The final guidance does have some interesting examples of how the FDA views promotional language in various scenarios.  As noted, “Section 351(k) of the PHS Act provides an abbreviated licensure pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed reference product.  Section 351(i) of the PHS Act defines biosimilarity to mean ‘that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components’ and that ‘there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.’”  The FDA has been clear in its thinking that a product that meets the definition of being highly similar to the reference biologic product should be interchangeable; however, there is a statutory issue that prevents the Agency, at this time, from automatically recognizing the lack of distinction.  We also know that the FDA has evaluated certain biosimilar products and concluded that they are interchangeable without the need for switching studies.  Thus, in some cases, the Agency has used available data for the highly similar nature of the biosimilars to make the determination of interchangeability.

The guidance document sort of tiptoes around the issue without coming right out and saying that biosimilars should all be considered interchangeable.  The movement towards this end continues within the Agency and Congress but, for now, this guidance document provides a good outline of what can and what cannot be said in promotional materials and labeling.