JAMA publishes Mylan and Biocon's proposed biosimilar trastuzumab Phase III data

Published study results showed an overall response rate of 69.6% for MYL-1401O compared to 64% for branded trastuzumab.

Dr Hope S. Rugo, professor of medicine at the University of California, San Francisco, commented: "We are encouraged by the confirmatory efficacy and safety results of the HERITAGE study recently published in JAMA. 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% for MYL-1401O compared to 64% for branded trastuzumab. Tumour progression, progression-free survival and overall survival was not statistically different between proposed biosimilar trastuzumab and branded trastuzumab at week 48."

Mylan President Rajiv Malik added: "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. Phase III study results show that a biosimilar can deliver similar efficacy in comparison to a branded product. Once approved, we believe our proposed biosimilar trastuzumab will provide a lower cost treatment option for breast cancer patients. We look forward to continuing our industry-leading role with Biocon to expand patient access across the globe to this critically important medicine as well as Mylan's broad portfolio of 15 additional biologics and insulin analogs currently in development."

Dr Narendra Chirmule, Sr. Vice President & Head R&D, Biocon, said: "The development of biosimilars requires a systematic scientific approach from design of the process to development. Biocon and Mylan have a scientifically rigorous, ethically compliant and structured development strategy to establish comparative safety and efficacy of our products. The global clinical progress of our various biosimilars programs demonstrates the strength of our R&D capabilities in this area. We are pleased that JAMA has published the clinical study results of trastuzumab after its very rigorous peer review process."

The HERITAGE data was submitted by Mylan to the FDA as part of the biologics license application (BLA) for MYL-1401O last month.