The U.S. Food and Drug Administration (FDA) has announced the establishment of a public docket to collect information and comments that will help advance the development of new biosimilar products. This initiative is part of the Biosimilar User Fee Amendments of 2022 (BsUFA III). The FDA is seeking industry input on whether biosimilar product development would benefit more from product class-specific guidance documents or product-specific guidance documents.
The FDA has emphasized the importance of industry feedback in shaping the future of biosimilar product development. By engaging with stakeholders, the FDA aims to determine the most effective approach to support the development of biosimilars. The agency is considering whether to focus on guidance documents that address common development issues across a broad class of products or to develop product-specific guidance, similar to the approach taken in the Generic Drug User Fee Amendments (GDUFA) program.
Key Questions for Industry Feedback
The FDA is specifically seeking input on several key questions such as; Which would be more useful for accelerating biosimilar development—product-specific guidance or product class-specific guidance? or Should the FDA focus on developing guidance for biological products with no approved biosimilars, or continue to develop guidance even after one or more biosimilars have been approved for that product or class?
The BsUFA III authorizes the FDA to collect user fees for certain activities related to biosimilar product development and review. An application under section 351(k) of the Public Health Service Act must demonstrate that a proposed biosimilar product is highly similar to an FDA-licensed reference product. The FDA has committed to developing guidance documents focusing on formal meetings between the agency and sponsors or applicants of BsUFA products, as well as topics related to interchangeable biosimilar biological products.
Action Plan and Performance Goals
As part of the BsUFA III program, the FDA has updated its biosimilar action plan and is exploring ways to advance the development of new biosimilar products. The FDA’s guidance documents, when finalized, represent the agency’s current thinking and aim to enhance scientific and regulatory clarity for the biosimilar product development community.
The feedback collected through this public docket will play a crucial role in shaping the future of biosimilar development. It will help the FDA determine the best approach to support the development of these products, ensuring that they meet the highest standards of safety and efficacy.
Resource: The Daily Journal of The United States Government, July 25, 2024
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