FDA Seeks Public Input on Biosimilar Development Guidance

The FDA has opened a public docket seeking input on their new guidance for biosimilar product development, with the agency having invited stakeholders to provide feedback on scientific and regulatory considerations for biosimilar and interchangeable biologics. The initiative aims to refine and enhance the development process for these emerging products and encourages the scientific public to submit comments and suggestions to help shape future policies and regulatory frameworks.

Background:

The Biosimilar User Fee Act reauthorization, known as BsUFA III,[1] authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar product development and review of applications submitted under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)). An application submitted under section 351(k) of the PHS Act must demonstrate, among other things, that a proposed biosimilar product is highly similar to, and has no clinically meaningful differences from, an FDA-licensed reference product. To date, FDA has issued a series of guidance documents to facilitate development of biosimilar products. Under section 351(k)(8)(D) of the PHS Act, if FDA issues product class-specific guidance with respect to the licensure of biosimilar products, the guidance must include a description of the criteria that FDA will use to determine whether a biological product is highly similar to a reference product in such product class and the criteria, if available, that FDA will use to determine whether a biological product meets the standards for interchangeability described in section 351(k)(4) of the PHS Act.

Under BsUFA III, FDA has committed to, among other things, the development of guidance documents focusing on formal meetings between FDA and sponsors or applicants of BsUFA products and topics related to interchangeable biosimilar biological products (interchangeable biosimilars or interchangeable biosimilar products) (see Biosimilar Biological Product Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027, available at https://www.fda.gov/​media/​152279/​download). These guidance documents are not product-specific or product class-specific but rather apply across many products and product classes. In contrast, under the GDUFA science and research 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.

As part of the BsUFA III program, FDA has updated its biosimilar action plan [2] and is revisiting how best to advance the development of new biosimilar products. FDA guidance can enhance scientific and regulatory clarity for the biosimilar product development community and, when finalized, represents FDA's current thinking on the matter.

Issues for Consideration and Request for Information and Comments:

FDA is seeking input from industry on whether product-specific guidance outlining the development program for a particular product would be valuable to the biosimilar product development community. A model for this approach is the GDUFA science and research program that, among other things, supports the issuance of product-specific guidance documents, of which there are currently over 2,000.[3]

Alternatively, FDA is seeking input on whether product class-specific guidance, which may apply more broadly to a class of products, would be valuable to the biosimilar product development community. Specifically, FDA is seeking input on the following questions:

1. Which would be more useful for accelerating biosimilar development: guidance documents 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 documents for biological products (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 even after one or more biosimilar products have been approved for that biological product or class of biological products?

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