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U.S. Department of Health and Human Services

About FDA

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 - 2014

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Oct 2013N/A34
Nov 2013N/A37
Dec 2013N/A40
Jan 2014N/A41
Feb 2014N/A41
Mar 2014N/A42
Apr 2014N/A43
May 2014N/A43
Jun 2014N/A44
Jul 2014N/A45
Aug 2014N/A47
Sep 2014N/A47

FY 2014 Cumulative Total: 47


  • 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.