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  1. FDA-TRACK: Agency-wide Program Performance

FDA-TRACK: Biosimilar User Fee Act (BsUFA) Performance

 

 

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FDA-TRACK: Drugs
FDA-TRACK: Biologics
BsUFA Performance Dashboard User Guide
FDA-TRACK Home

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 2022 (BsUFA III), authorizes FDA to assess and collect fees for biosimilar biological products from October 2023 through September 2027. 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 2023 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, 2023. The BsUFA Dashboards present final performance in meeting BsUFA goals for FY 2022 and preliminary performance for FY 2023. Final BsUFA performance data for FY 2023 will be presented in the FY 2024 BsUFA Report and referenced in updated versions of the BsUFA Dashboards.

FDA-Track icon: BsUFA Biosimilar Applications and Supplements

Biosimilar Applications and Supplements

The Biosimilar Applications and Supplements Dashboard displays current performance relating to the review of:

  • Original Biosimilar Product Applications
  • Resubmitted Original Biosimilar Applications
  • Original Supplements with Clinical Data
  • Resubmitted Supplements with Clinical Data
  • Original Supplemental Biosimilar Biological Product Applications- Category A, B, C, D, E, and F
  • Resubmitted Supplemental Biosimilar Biological Product Applications- Category A, B, C, D, E, and F
  • 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 Supplements with Clinical Data
  • Planned Review Timeline for Supplements with Clinical Data
  • Receipt and Planned Review Timeline for Original Category A through D Supplements
  • Issues Identified During the Filing Review for Category E and F Supplements
  • Proprietary Names Submitted During Biosimilar Biological Product Development (BPD) Phase and During Application Review
FDA-TRACK: BsUFA Procedural Notifications
FDA-TRACK: BsUFA Procedural Responses

Procedural Responses

The Procedural Responses Dashboard displays current performance relating to the review of/responses to:

  • Major Dispute Resolutions
  • Response to Clinical Holds
  • Special Protocol Assessments
  • Human Factors Protocol Submissions to INDs

Meeting Management

The Meeting Management Dashboard displays current performance relating to the response to/issuance of:

  • Biosimilar Initial Advisory Meeting Requests
  • BPD Type 1, 2, 2a, 2b, 3, and 4 Meeting Requests
  • Biosimilar Initial Advisory Meetings Scheduled
  • BPD Type 1, 2, 2a, 2b, 3, and 4 Meetings Scheduled
  • Biosimilar Initial Advisory Written Response
  • BPD Type 2, 2a, and 2b Written Response
  • Preliminary Response for BPD Type 2, 2b, and 3 Meetings
  • Meeting Minutes for All Meeting Types
FDA-TRACK icon: BsUFA Meeting Management

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