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DECEMBER 4, 2017

FDA Approves Biosimilar Ogivri for Breast, Stomach Cancers

The FDA approved trastuzumab-dkst (Ogivri, Mylan-Biocon) as a biosimilar to trastuzumab (Herceptin, Genentech) for the treatment of patients with breast or metastatic breast, gastric or gastroesophageal junction adenocarcinoma whose tumors overexpress the HER2 gene. 

Trastuzumab-dkst is the first biosimilar approved in the United States for the treatment of breast cancer or stomach cancer, and the second biosimilar approved for the treatment of cancer. Ogivri has been approved as a