On March 7, 2022, the US Food and Drug Administration (FDA) issued a Funding Opportunity Announcement (FOA) to commit up to $5 million in fiscal year 2022 toward several research proposals. Specifically, the FDA anticipates awarding as many as five proposals up to $1 million in funding. This FOA arises out of the FDA’s proposed commitments in the third proposed Biosimilar User Free Act, through which it intends to “explor[e] ways to enhance biosimilar and interchangeable biosimilar product development and regulatory science.”
With this FOA, the FDA intends to “address a diversity of topics related to improving the efficiency of biosimilar product development and advancing the development of interchangeable biological products.” Qualifying proposals may cover a range of subjects, including but not limited to, evaluating methodologies and standards for predicting biologic immunogenicity and streamlining biosimilar product development. Proposed projects must, however, apply across more than one product or product class and produce an intended outcome that is translatable to regulatory expectations. The FDA will accept proposals through May 9, 2022 and expects projects to begin no earlier than September 2022.