Ogivri FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 26, 2019.
FDA Approved: Yes (First approved December 1, 2017)
Brand name: Ogivri
Generic name: trastuzumab-dkst
Dosage form: for Injection
Company: Mylan GmbH
Treatment for: Breast Cancer, Gastric 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 timeline for Ogivri
| Date | Article |
|---|---|
| Dec 1, 2017 | Approval 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 |
Further information
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