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Ogivri Approval History

  • FDA approved: Yes (First approved December 1st, 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

DateArticle
Dec  1, 2017Approval FDA Approves Ogivri (trastuzumab-dkst), a Biosimilar to Herceptin
Jan 11, 2017U.S. FDA Accepts Biologics License Application (BLA) for Mylan and Biocon's Proposed Biosimilar Trastuzumab

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