On Dec. 1, 2017, the U.S. Food and Drug Administration (FDA) approved Mylan’s Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors over express the HER2 gene (HER2+).

Ogivri was the first biosimilar approved in the U.S. for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the U.S. for the treatment of cancer. Herceptin was approved in September 1998 , manufactured by Genentech.