Posted by Michael Wonder on 02 Dec 2017
FDA approves first biosimilar for the treatment of certain breast and stomach cancers
1 December 2017 - The U.S. FDA 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.
Ogivri is 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.
The FDA granted approval of Ogivri to Mylan. Herceptin was approved in September 1998 and is manufactured by Genentech.
