FDA-TRACK: Biosimilar User Fee Act Performance
Biosimilar Applications and Supplements
Procedural Notifications
Procedural Responses
Meeting
Management
The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Amendments of 2017 (BsUFA II), authorizes FDA to assess and collect fees for biosimilar biological products from October 2017 through September 2022. FDA dedicates these fees to expediting the review process for biosimilar biological products, facilitating the development of safe and effective biosimilar products for the American public.
The Biosimilar User Fee Performance Dashboards (BsUFA Dashboards) provide a concise, interactive, and visual presentation of data that is presented in the legislatively mandated FY 2022 BsUFA Performance Report to Congress for the Biosimilar User Fee Act (the Report). The BsUFA Dashboards are not intended to replace the Report and are to be used as a supplemental tool for viewing the data. The BsUFA Dashboards reflect performance on submissions received and actions taken as of September 30, 2022. The BsUFA Dashboards present final performance in meeting BsUFA goals for FY 2021 and preliminary performance for FY 2022. Final BsUFA performance data for FY 2022 will be presented in the FY 2023 BsUFA Report and referenced in updated versions of the BsUFA Dashboards.
Biosimilar Applications and Supplements
The Biosimilar Applications and Supplements Dashboard displays current performance relating to the review of:
- Original Biosimilar Product Applications
- Resubmitted Biosimilar Product Original Applications
- Original Supplements with Clinical Data
- Manufacturing Supplements Requiring Prior Approval
- Manufacturing Supplements Not Requiring Prior Approval
Procedural Notifications
The Procedural Notifications Dashboard displays current performance relating to the notification/review of:
- Issues Identified During Filing Review for Original Applications and Supplements with Clinical Data
- Planned Review Timeline for Original Applications with Clinical Data
- Proprietary Names Submitted During Biosimilar Biological Product Development (BPD) Phase and During Application Review
Procedural Responses
The Procedural Responses Dashboard displays current performance relating to the review of/responses to:
- Major Dispute Resolutions
- Responses to Clinical Holds
- Special Protocol Assessments
Meeting Management
The Meeting Management Dashboard displays current performance relating to the response to/issuance of:
- Meeting Requests
- Scheduling Meetings
- Written Responses
- Preliminary Responses
- Meeting Minutes
