Mylan's Herceptin biosimilar gets FDA approval

FDA approved Ogivri trastuzumab-dkst from Mylan N.V. (NASDAQ:MYL; Tel Aviv:MYL), a biosimilar of cancer drug Herceptin trastuzumab. The agency said Ogivri is the first biosimilar approved in the U.S. to treat breast cancer or stomach cancer and the second biosimilar approved in the U.S. to treat cancer.

Ogivri is indicated for all cancer types on Herceptin's label, including HER2-positive breast cancer and metastatic gastric cancer. Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech Inc. unit market Herceptin, a humanized mAb against HER2...