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U.S. Department of Health and Human Services

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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, 2017.

Fiscal Year - 2018

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Oct 2017N/A0
Nov 2017N/A0
Dec 2017N/A1
Jan 2018N/ATBD
Feb 2018N/ATBD
Mar 2018N/ATBD
Apr 2018N/ATBD
May 2018N/ATBD
Jun 2018N/ATBD
Jul 2018N/ATBD
Aug 2018N/ATBD
Sep 2018N/ATBD

FY 2018 YTD: 1


  • 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.