Pending Biosimilars
Executive Summary
Biosimilar applications using the 351(k) pathway under review at US FDA. Updated upon new submissions.
The official 351(k) pathway for biosimilar products was created in the Biologics Price Competition and Innovation Act, a component of the health care reform law. Listed below are biologics license applications (BLAs) submitted under that pathway.
Biosimilar sponsors also can submit their products using the 505(b)2 NDA or conventional BLA pathways; those applications are only listed in the FDA Performance Tracker's User Fee Goal Dates chart, a comprehensive listing of new and supplemental new drug applications (NDAs) and BLAs. The User Fee Goal Dates chart also includes 351(k) filings; this chart provides additional information about the applications.
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