On June 3, Mylan N.V. and Biocon Ltd. presented phase 3 clinical data regarding their trastuzumab product (dubbed MYL-1401O), which is a proposed biosimilar to Genentech’s Herceptin, at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting. Trastuzumab is indicated for the treatment of HER2-positive metastatic breast cancer patients, and for adjuvant treatment of HER2 overexpressing breast cancer and metastatic gastric cancer. According to Mylan, Mylan’s product successfully met the predefined endpoints of equivalency, including safety and efficacy measures. Mylan also stated that the results will enable Mylan and Biocon to file for regulatory approval.
Blog Big Molecule Watch June 08, 2016