Photo: Hemant Mishra/MintThe US Food and Drug Administration (FDA) on Friday approved Mylan N.V. and Biocon Ltd’s biosimilar for Roche’s drug Herceptin, used in the treatment of breast and metastatic stomach cancer. Mylan-Biocon’s trastuzumab, to be sold under the name Ogivri, is the first biosimilar approved in the US for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the country for cancer treatment, US FDA said in a release. “Ogivri is the first FDA-approved biosimilar to Herceptin and the first biosimilar from Mylan and Biocon’s joint portfolio approved in the US. Mylan and Biocon’s biosimilar for Herceptin also is under review by regulatory authorities in Australia, Canada, Europe and several additional markets. In the US, an estimated 250,000 new cases of female breast cancer and 28,000 new cases of stomach cancer are expected to be diagnosed in 2017 alone.

Source: Mint December 01, 2017 19:30 UTC