FDA Announces BsUFA III Regulatory Science Program to Support Future Research

FDA published a funding opportunity announcement (FOA) for fiscal year 2023 to support research projects that improve biosimilars, interchangeable biological product development, and regulatory science. The Biosimilar User Fee Act (BsUFA) reauthorization commitment letter for fiscal years 2023–2027 (BsUFA III) highlights that FDA will start a regulatory science program to facilitate biosimilar and interchangeable biological product development. The intention of the FOA is to address diverse topics related to improving the efficiency of biosimilar product development and advancing the development of interchangeable products.

The target of these projects includes:

• Increasing the accuracy and capability of analytical characterizations, like physical, chemical, and biological function, and chemistry, manufacturing, and controls

• Creating alternatives to and/or reducing the size of studies involving human subjects.

Further, the FOA provides details on projects of particular interest to support the overall research, such as the use of analytical device information, identification of user interface differences, and development of methods and/or principles to help determine acceptable differences.

Source: FDA