BRIEF—FDA BsUFA III regulatory science program funding opportunity

The US Food and Drug Administration yesterday published a  funding opportunity announcement (FOA) for fiscal year 2023 to support research projects that enhance biosimilar and interchangeable biological product development and regulatory science.

As the Biosimilar User Fee Act (BsUFA) reauthorization  commitment letter for fiscal years 2023-2027 (BsUFA III) outlines, the FDA will pilot a regulatory science program to facilitate biosimilar and interchangeable biological product development. The purpose of this FOA is to address diverse topics related to improving the efficiency of biosimilar product development and advancing the development of interchangeable products. The scope of submitted projects should aim to focus on the following:

1) Increasing the accuracy and capability of analytical characterizations (including physical, chemical and biological function) and chemistry, manufacturing, and controls.

2) Developing alternatives to and/or reducing the size of studies involving human subjects.

In addition, 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

The funding opportunity will be open for submissions until April 26, 2023.