BsUFA II: Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act
Over the years, FDA has worked to increase communication between Agency staff and applicants during the review of novel drug and original biologic applications. The goal has been to enhance the transparency, predictability, effectiveness, and efficiency of the review process. As part of the reauthorization of the Biosimilar User Fee Act (BsUFA II), FDA committed to a similar model for the review of biosimilar Biologics License Applications (BLAs) submitted under section 351(k) of the Public Health Service Act (“351(k) BLAs”).
The key features of the Program include:
- new opportunities for communication between applicants and the FDA review team during the agency’s review of the application
- additional review clock time for the agency to meet with applicants during review as well as to address review activities that occur late in the review cycle for these applications
- an interim and final assessment that will evaluate whether the parameters of the Program have achieved the intended goals.
This page contains information relevant to the assessments as well as other communications related to the Program. Additional details about the Program can be found in Section IB of the BsUFA Commitment Letter.
Assessment of the Program
- Interim Assessment
- Final Assessment (PDF -1 MB)