Ogivri Approval History
Ogivri (trastuzumab-dkst) is a HER2/neu receptor antagonist biosimilar to Herceptin indicated for the treatment of HER2-overexpressing breast cancer and the treatment of HER2-overexpressing stomach cancer.
Development History and FDA Approval Process for Ogivri
|Dec 1, 2017||FDA Approves Ogivri (trastuzumab-dkst), a Biosimilar to Herceptin|
|Jan 11, 2017||U.S. FDA Accepts Biologics License Application (BLA) for Mylan and Biocon's Proposed Biosimilar Trastuzumab|
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