As part of the Biosimilar User Fee Amendments of 2022 (BsUFA III) program, FDA is revisiting how best to advance the development of new biosimilar products. Currently, FDA has committed to developing guidance documents focusing on formal meetings between FDA and sponsors or applicants of BsUFA products and topics related to interchangeable biosimilar biological products. These guidance documents are neither product-specific nor product class-specific, but instead apply across many products and classes.

In contrast, under the Generic Drug User Fee Amendments (GDUFA) program, FDA conducts research in support of various regulatory science initiatives, the results of which support development of both general and product-specific guidance for industry. These guidance documents provide recommendations to industry on establishing bioequivalence, active ingredient sameness, as well as device sameness. Once published, FDA provides opportunity for public comment on the recommendations. FDA is now considering a similar approach for biological products and is seeking comments in a new docket on whether product-specific guidances outlining the development program for a particular product would be valuable to the biosimilar product developers.

Specifically, FDA seeks input on these two questions:

1. Which would be more useful for accelerating biosimilar development: guidances that focus on a particular product (“product-specific guidance”), or guidance documents that are cross-cutting for a class of biosimilar products (“product class-specific guidance”), such as monoclonal antibodies?

2. Should FDA focus on development of guidance for biologics (or classes of biological products) for which there are no approved biosimilars, or would it be useful for FDA to continue to develop guidance on biosimilar development programs after one or more biosimilar products have been approved for that biological product or class of biological products?

FDA invites comments on the draft guidance through October 23, 2024. If you may want to submit a comment, or have questions on biological products more generally, please contact any of the authors of this alert or the Hogan Lovells attorney with whom you regularly work.

Authored by Komal Karnik Nigam, Deborah Cho, and Bryan Walsh