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

Date	Article
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

Further information

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