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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 - 2015

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Oct 2014N/A50
Nov 2014N/A51
Dec 2014N/A51
Jan 2015N/A52
Feb 2015N/A50
Mar 2015N/A52
Apr 2015N/ATBD
May 2015N/ATBD
Jun 2015N/ATBD
Jul 2015N/ATBD
Aug 2015N/ATBD
Sep 2015N/ATBD

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.