In a pre-publication Federal Register notice issued today (here), the FDA announced a draft guidance titled Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers: Guidance for Industry (here) to further promote the Agency’s knowledge and view that biosimilars and interchangeable biosimilars are really the same (although the Agency doesn’t come right out and state that).
Initially, as stated in the aforementioned Federal Register notice, “FDA did not provide recommendations for interchangeable biosimilar products because FDA had limited knowledge and experience regarding manufacturing changes for licensed interchangeable biosimilar products when that guidance issued. FDA has since determined that the principles that apply to manufacturing changes for biosimilars are relevant to interchangeable biosimilar products. Thus, this draft guidance applies to manufacturing changes made to both licensed biosimilar and licensed interchangeable biosimilar products.” The FDA further notes that question I.20 in the Q&A biosimilar development guidance (here), which did not address post-approval changes for interchangeable biosimilars, will be removed from the guidance once the just-published draft Q&A guidance document is finalized.
This is another big step in advancing the FDA’s apparent, current belief that there is no safety or efficacy difference that can be expected between biosimilars and interchangeable biosimilars. This represents (in my opinion) a move towards a public acknowledgement in that direction. We do, however, need to wait and see whether, after the Chevron decision, the FDA will be challenged on the Biosimilar Act in which two types of biosimilars are defined, which could potentially impact the likelihood of the Agency making an official statement that there is really one class of biosimilars and all are interchangeable when approved, much like the generic drug approval process provides.
