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U.S. Department of Health and Human Services

About FDA

Number of biosimilar investigational new drug applications (INDs) received in the month

Dictionary: Biosimilar investigational new drug application refers to an investigation that FDA determines is intended to support a biosimilar biological product application for a product.

Information is current as of December 31, 2014.

Fiscal Year - 2013

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Oct 2012N/AN/A
Nov 2012N/AN/A
Dec 2012N/AN/A
Jan 2013N/A0
Feb 2013N/A2
Mar 2013N/A1
Apr 2013N/A1
May 2013N/A0
Jun 2013N/A0
Jul 2013N/A1
Aug 2013N/A0
Sep 2013N/A0

FY 2013 Total: 5


  • CDER began collecting data for this measure in January 2013.


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.