Ogivri Approval History
- FDA approved: Yes (First approved December 1, 2017)
- Brand name: Ogivri
- Generic name: trastuzumab-dkst
- Company: Mylan GmbH
- Treatment for: Breast Cancer, Stomach Cancer
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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