Cumulative number of biosimilar development programs in the BPD Program in the month
Dictionary: Biosimilar biological product development (BPD) program refers to FDA’s program for expediting the process for the review of submissions in connection with biosimilar biological product development.
Information is current as of March 31, 2015.
Fiscal Year - 2015
FY 2015 Cumulative Total: 52
- CDER began collecting data for the these measures in January 2013.
- A biosimilar product is no longer in the BPD program after a 351(k) BLA is accepted for review (i.e., filed)
Note: 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. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.