Mylan and Biocon launch Ogivri in the US, being the first biosimilar trastuzumab approved by the FDA.
Mylan N.V. and Biocon Ltd. announced the U.S. launch of Ogivri (trastuzumab-dkst), a biosimilar to Herceptin (trastuzumab). Ogivri is available in a 420mg multi-dose vial and a 150mg single-dose vial in order to provide patient dosing and treatment flexibility. Ogivri was the first biosimilar trastuzumab approved by the FDA and unanimously recommended by the FDA Oncologic Drugs Advisory Committee (ODAC).
Ogivri is approved for all indications of Herceptin including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma).
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