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News From the Food and Drug Administration
January 16, 2018

Second Cancer Biosimilar Approved

JAMA. 2018;319(3):220. doi:10.1001/jama.2017.20642

The FDA recently approved the first biosimilar for patients with certain breast or stomach cancers. Marketed as Ogivri, trastuzumab-dkst is the second biosimilar approved in the United States to treat cancer.

Trastuzumab-dkst is biosimilar to trastuzumab, a monoclonal antibody that was approved in 1998 and is sold under the brand name Herceptin. The newly approved biosimilar is indicated for patients with breast or metastatic stomach tumors that are ERBB2 (formerly human epidermal growth factor receptor 2 [HER2] or HER2/neu) positive.