FDA funds regulatory science pilot for biosimilars

Home/Policies & Legislation | Posted 25/03/2022 post-comment0 Post your comment

The US Food and Drug Administration (FDA) has announced US$5 million funding for research proposals under the Biosimilar User Fee Act  (BsUFA III) Regulatory Science Pilot Program.

Guidance V13F21

On 7 March 2022, FDA announced a new funding opportunity for research proposals, under the regulatory science pilot for biosimilars. The funding totals US$5 million and comes under the upcoming BsUFA III programme, which will run from 2023–2027.

FDA released the Performance Goals Letter for BsUFA III in September 2021 [1], outlining a number of key provisions including advancing development of interchangeable biosimilars, enhancing inspection-related communications and modernizing facility assessment approaches.

The programme aims to advance development of interchangeable products and to make biosimilar development more efficient. An interchangeable biological is defined by FDA as a ‘biosimilar that meets additional requirements outlined by the law that allows for the FDA to approve biosimilar and interchangeable medications’ [2]. The agency approved the first interchangeable biosimilar in July 2021 in the form of Mylan’s insulin glargine biosimilar Semglee [3].

The Agency 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 interchangeables.

Up to US$1 million per award, per year is available for projects addressing significant issues with the development of biosimilars or interchangeables. Up to five awards are possible in total. The Agency will review the proposals in advance of BsUFA’s authorization, which must still be approved by congress. It notes that all awards are subject to funding and the re-authorization of BsUFA III.

The Agency is seeking applications from 9 May 2022 with accepted projects to begin from September 2022.

The Agency says it is looking at proposals across a range of topics, including evaluating methodologies and standards to predict immunogenicity and opportunities for more streamlined biosimilar development. Proposals must be applicable across more than one product or product class and provide data that are of ‘sufficient reliability, quality and impact to support or be a critical milestone in changes in regulatory expectations.’

In terms of project types, the Agency says it welcomes a range, including analytical methodology, bioassay development, in silico tools, real-world evidence, pharmacology studies and ancillary studies in parallel to clinical trials, but says it is particularly interested in projects that ‘efficiently and convincingly achieve intended objectives.’ Novel methods and tools can also be used but must be validated or have a feasible approach to validation.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilar User Fee Act (III) performance goals letter published [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Mar 25]. Available from: www.gabionline.net/guidelines/biosimilar-user-fee-act-iii-performance-goals-letter-published
2. GaBI Online - Generics and Biosimilars Initiative. FDA releases new information on interchangeable biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Mar 25]. Available from: www.gabionline.net/biosimilars/general/FDA-releases-new-information-on-interchangeable-biologicals
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable insulin glargine biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Mar 25]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-insulin-glargine-biosimilar

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Source: US FDA

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