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

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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.