The US Food and Drug Administration (FDA) on Thursday released a roadmap on its science and research priorities for fiscal years 2023-2027 to spur the development of biosimilars and interchangeable products.
Under the Biosimilar User Fee Amendments (BsuFA) III program, FDA has offered $5 million in funding for several research proposals under the regulatory science pilot program (RELATED: FDA offers funding for biosimilar regulatory science pilot, Regulatory Focus, 7 March 2022).
The BsUFA III regulatory research pilot program has two goals: advancing the development of interchangeable products and improving the efficiency of biosimilar product development. As part of these goals, FDA announced that its research priorities are to increase the accuracy and capability of analytical and chemistry, manufacturing, and controls (CMC) characterization of biosimilar products and develop alternatives to human studies.
FDA announced that “researchers, both external and internal to FDA, should use this roadmap to guide research proposals, collaborations, and other efforts as they seek BsUFA III research funding opportunities. The roadmap also includes information on research project deliverable dates and methods to consider for research conducted as part of the pilot program.”
The first research area will cover defining and standardizing approaches for assessing and reporting product quality attributes and assessing the impact of differences of biosimilar or interchangeable and reference products.
The second research area will look at developing alternatives to human studies. “Recent efforts have resulted in alternatives to comparative clinical studies for certain biosimilars such as use of a pharmacodynamic (PD) biomarkers (absolute neutrophil count) for development of a pegfilgrastim product as a biosimilar,” according to the roadmap.
FDA also opened a public docket to obtain feedback on this roadmap.
Under the terms of the BsUFA commitment letter, FDA must publish an interim progress report and workshop on this research on or before 31 October 2025, and a final summary report of the outcomes from the pilot on or before 30 September 2027. FDA also must publish a strategy document on its learnings from these projects and outline actions it will take to facilitate the development of biosimilar and interchangeable products.
BsUFA III Research Roadmap
Under the Biosimilar User Fee Amendments (BsuFA) III program, FDA has offered $5 million in funding for several research proposals under the regulatory science pilot program (RELATED: FDA offers funding for biosimilar regulatory science pilot, Regulatory Focus, 7 March 2022).
The BsUFA III regulatory research pilot program has two goals: advancing the development of interchangeable products and improving the efficiency of biosimilar product development. As part of these goals, FDA announced that its research priorities are to increase the accuracy and capability of analytical and chemistry, manufacturing, and controls (CMC) characterization of biosimilar products and develop alternatives to human studies.
FDA announced that “researchers, both external and internal to FDA, should use this roadmap to guide research proposals, collaborations, and other efforts as they seek BsUFA III research funding opportunities. The roadmap also includes information on research project deliverable dates and methods to consider for research conducted as part of the pilot program.”
The first research area will cover defining and standardizing approaches for assessing and reporting product quality attributes and assessing the impact of differences of biosimilar or interchangeable and reference products.
The second research area will look at developing alternatives to human studies. “Recent efforts have resulted in alternatives to comparative clinical studies for certain biosimilars such as use of a pharmacodynamic (PD) biomarkers (absolute neutrophil count) for development of a pegfilgrastim product as a biosimilar,” according to the roadmap.
FDA also opened a public docket to obtain feedback on this roadmap.
Under the terms of the BsUFA commitment letter, FDA must publish an interim progress report and workshop on this research on or before 31 October 2025, and a final summary report of the outcomes from the pilot on or before 30 September 2027. FDA also must publish a strategy document on its learnings from these projects and outline actions it will take to facilitate the development of biosimilar and interchangeable products.
BsUFA III Research Roadmap
