Regulatory science research is an important component of the work the FDA does to facilitate the evaluation and development of FDA-regulated products - and to support regulatory decision-making and policy development. FDA is committed to helping facilitate the timely development of biosimilar and interchangeable biosimilar products and has been working to create the infrastructure needed to support a new biosimilar regulatory science pilot program. As outlined in the biosimilar user fee act (BsUFA) reauthorization commitment letter for fiscal years 2023-2027 (BsUFA III), FDA will pilot a regulatory science program to further advance biosimilar and interchangeable biological product development. The program will focus on enhancing regulatory decision-making and facilitating science-based recommendations in areas foundational to biosimilar and interchangeable product development.
FDA is exploring ways to enhance biosimilar and interchangeable biosimilar product development and regulatory science in this new pilot, specifically in two areas: improving the efficiency of biosimilar product development and advancing the development of interchangeable products. To support the new biosimilar regulatory science program, FDA issued a funding opportunity announcement to solicit projects that can help to advance these goals and a created a new website.
Ultimately, the projects and research studies undertaken through the biosimilar regulatory science program are expected to contribute to the development and review of biosimilar and interchangeable products. The availability of these products can provide more treatment options for patients, increase access to lifesaving medications, and potentially lower health care costs through competition.
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