BRIEF—FDA approves first biosimilar for the treatment of certain breast and stomach cancers

The US Food and Drug Administration today approved 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 overexpress the HER2 gene (HER2+).

The FDA granted approval of Ogivri to Mylan, which is developing the copycat version with India’s Biocon. Herceptin was approved in September 1998 and is manufactured by Genentech, a subsidiary of Swiss pharma giant Roche.

Ogivri is the first biosimilar approved in the USA for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the USA for the treatment of cancer.

“The FDA continues to grow the number of biosimilar approvals, helping to promote competition that can lower health care costs. This is especially important when it comes to diseases like cancer, that have a high cost burden for patients,” said FDA Commissioner Scott Gottlieb, adding: “We’re committed to taking new policy steps to advance our biosimilar pathway and promote more competition for biological drugs.”