FDA-TRACK: Center for Drug Evaluation & Research - Pre-Approval Safety Review - Biosimilars Dashboard
FDA-TRACK is FDA's agency-wide performance management program that monitors, analyzes and reports key performance data and projects for FDA's program offices and cross-cutting initiatives.
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.
For a complete list of CDER measures and their relevant FDA-TRACK dashboard, refer to the FDA-TRACK CDER Index.