Mylan, Biocon release results for new trastuzumab study

Mylan N.V. and Biocon Ltd. released results of their Heritage Study in the Journal of the American Medical Association (JAMA), showing positive indications for MYL-1401O, the proposed biosimilar trastuzumab co-developed by Mylan and Biocon.
"We are encouraged by the confirmatory efficacy and safety results of the HERITAGE study recently published in JAMA,” Dr. Hope S. Rugo, professor of medicine at the University of California, San Francisco, said. “This study was the last major step of a multiple-phased program to demonstrate that proposed biosimilar trastuzumab meets the criteria for equivalence in comparison to branded trastuzumab."
Published study results showed an overall response rate of 69.6 percent for MYL-1401O compared to 64 percent for branded trastuzumab. Tumor progression, progression-free survival and overall survival was not statistically different between proposed biosimilar trastuzumab and branded trastuzumab at week 48.
The companies submitted the data from the study to the U.S. Food and Drug Administration in an effort to secure a biologics license application for the product.
"We are proud that JAMA has recognized the results of the HERITAGE study and are encouraged that the proposed biosimilar trastuzumab, MYL-1401O, could provide an effective treatment option for metastatic breast cancer patients,” Mylan President Rajiv Malik said.