Praise for BsUFA Statement of Work
Four stakeholder organizations are praising the FDA program for enhanced review transparency and communication statement of work that was negotiated as part of the Biosimilars User Fee Agreement. The Association for Accessible Medicines (formerly the Generic Pharmaceutical Association) and its Biosimilars Council say the need to provide adequate agency resources was highlighted during the user fee negotiations, and specific hiring commitments were made. “We applaud allocation of dedicated FDA resources to ensure comprehensiveness, consistency, and timeliness of the review process,” the two groups write. “We encourage the agency to hire and train the necessary staff as quickly as possible.”
The Biotechnology Innovation Organization (BIO) says it supports the approach described in the user fee performance goals of establishing a review approach for biosimilar applications patterned generally after the program established under PDUFA 5 for new molecular entities and new BLAs. “With respect to that earlier program,” BIO writes, “a third-party evaluator determined that it has been successful in increasing the number of first-cycle approvals for those products. The underlying premise of both the previous and the proposed programs was that increased and improved communication between FDA and the application sponsor during the review would improve efficiency and reduce need for additional review cycles.”
BIO says that just as a third-party evaluator determined the success of the PDUFA 5 communication effort, it is equally important for such an evaluation to occur for the new biosimilars program. “We applaud FDA’s inclusion in the draft Scope of Work that the evaluation must be public, take account of input from both FDA staff and sponsors, and provide recommendation at the mid-point and at the end of the program for any changes that might be needed for the program to succeed. It is especially important, in the case of using this review approach for biosimilars applications, that the evaluator look at the relationship between the biosimilars development program meetings, which occur throughout the process of development and up to application submission, and the meetings that occur during the review cycle. The question of whether and to what extent those earlier meetings could have identified and provided time for resolution of potential problems is an important one, particularly as the proposed approach adds 60 days to the total time from application submission to user fee agreement goal date.”
The Biosimilars Forum notes that a key feature of the enhanced communication and transparency effort is the agency’s commitment to provide a third-party independent assessment of the program’s effectiveness in increasing the effectiveness of the first-cycle review process and minimizing the number of review cycles necessary for approval of biosimilar applications. It says it believes that the statement of work for the assessment activity accurately reflects the goals in the user fee commitment letter.
Finally, Sandoz praises FDA for publishing the statement of work before the user fee agreement reauthorization, anticipated for 10/1. “We also applaud FDA’s transparent approach in the draft statement of work that the evaluation must be public and include input from both FDA staff and sponsors to provide recommendations to potentially improve the program. The company says it continues to support the concept that user fees should be based on biosimilar workloads and since the industry is growing and developing, there might not be adequate information to project workload for the full five-year period and workload will need to be closely monitored for potential fluctuations.