FDA offers funding for biosimilar regulatory science pilot

Regulatory NewsRegulatory News | 07 March 2022 |  By 

The US Food and Drug Administration’s (FDA) is offering funding for several research proposals under the regulatory science pilot for biosimilars under the upcoming Biosimilar User Fee Amendments (BsUFA III) program, with a $5 million funding opportunity announced on Monday.
The agency and industry agreed to fund the regulatory science pilot during the negotiations for the third iteration of the agency’s biosimilar review program. The five-year program, which will run from FY2023-2027, must still be approved by Congress. (RELATED: Regulatory science pilot floated in BsUFA III negotiations, Regulatory Focus 15 June 2021; BsUFA III commitment letter details FDA, industry goals for biosimilars program, Regulatory Focus 21 September 2021)
The broad goals of the regulatory science program are to advance the development of interchangeable products and to make biosimilar development more efficient. The agency only recently approved Mylan's Semglee (insulin glargine-yfgn) as the first interchangeable biosimilar product. FDA says it will conduct research under the proposed BsUFA III Regulatory Science Pilot Program, develop "foundational guidance" and host a stakeholder workshop on the development of interchangeable products.
The newly announced funding opportunity calls for proposals, with up to five awards of $1-2 million possible. The agency notes that while it will review the proposals in advance of BsUFA’s passage, “All awards will be subject to funding and reauthorization of BsUFA.”
FDA said it hopes to “address a diversity of topics related to improving the efficiency of biosimilar products development and advancing the development of interchangeable biological products.” Some potential topical areas for projects include evaluating methodologies and standards to predict immunogenicity and looking at opportunities for streamlined and targeted biosimilar development.
The agency notes that proposals “must be applicable across more than one product or product class” and that the “resulting data must be of sufficient reliability, quality, and impact to support or be a critical milestone in changes in regulatory expectations.”
“A variety of project types are welcomed under this [funding opportunity announcement] FOA, including analytical methodology (including bioassay) development, in silico tools, real world evidence, pharmacology studies, ancillary studies in parallel to planned or ongoing clinical trials, and combinations of these project types,” FDA said.
The agency is “particularly interested in projects that efficiently and convincingly achieve intended objectives.” While novel methodologies and tools are welcomed, FDA said they must be validated or have a “feasible approach to validation” to be considered.
FDA is seeking applications through 9 May 2022, with accepted research projects beginning in September 2022 at the earliest. The agency said it will spend up to $5 million in FY2022 in support of the program and that it will grant up to five awards of $1 million per year.


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