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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

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

Further information

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