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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 - 2013

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Oct 2012N/AN/A
Nov 2012N/AN/A
Dec 2012N/AN/A
Jan 2013N/A20
Feb 2013N/A21
Mar 2013N/A24
Apr 2013N/A27
May 2013N/A28
Jun 2013N/A29
Jul 2013N/A31
Aug 2013N/A31
Sep 2013N/A32

FY 2013 Cumulative Total: 32


  • 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.