FDA-TRACK: Center for Drug Evaluation and Research - Pre-Approval Safety Review - Biosimilars Dashboard
A biosimilar is highly similar to, and has no clinically meaningful differences in safety, purity, and potency (safety and effectiveness) from, an existing FDA-approved reference (originator) product. The goal of a biosimilar development program is to demonstrate biosimilarity between the proposed biosimilar product and the reference product, not to independently establish the safety and effectiveness of the proposed product.
The manufacturer of a proposed biosimilar product generates an array of data comparing the proposed product to the FDA-approved reference product to demonstrate biosimilarity. The comparative data are generated and evaluated in a stepwise fashion that begins with a foundation of detailed analytical (structural and functional) characterization and comparison of the products, moving on to animal studies if necessary and then to comparative clinical studies.
Data contained in the dashboard is not final, but accurate at the time of posting; refer to the BsUFA Performance Reports to Congress for official data.
Download Biosimilars Dataset PDF / Print Version
- Data collection began with FY 16 submissions.
- Figures provided are Filed and Pending Filing figures (not Submitted) and exclude those submissions that are Refuse to File (RF), Withdrawn Before Filing (WF), or Unacceptable Due to Nonpayment of User Fees (UN). Pending filing refers to those submissions that have not yet reached the 60-day filing date.
- Figures include biosimilar BLAs only.
- Approval data includes full approval of actions taken on the original application and does not include supplements with clinical data.
- Meeting data represents industry requested meetings that are scheduled with CDER.
- Biosimilar Initial Advisory and BPD Type 2 WRO meetings were newly created under BsUFA II and, therefore, have no data prior to FY 18.
- A biosimilar product is no longer enrolled in the BPD program if participation in the BPD program is discontinued for the product or a biosimilar BLA for the product is accepted for review (i.e., filed).
- Number of WRO meetings scheduled include Biosimilar Initial Advisory and BPD Type 2 WRO meetings beginning in FY 18.
- Percentage of actions within goal includes actions on original submissions and resubmissions of the original application. This figure does not include actions on supplements with clinical data.
- Number of new biosimilar commercial INDs received.
- The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. The data presented in the visualizations above can be accessed by clicking on the link labeled "Download Biosimilars Dataset" located right below the visualizations.
- Data contained in the dashboard is not final, but accurate at the time of posting.