Branded Trastuzumab HERITAGE Study Published in JAMA

Mylan N.V. and Biocon today announced that the results of the HERITAGE study have been published in the Journal of the American Medical Association (JAMA).

Study results confirm the efficacy, safety and immunogenicity of MYL-14010, the proposed biosimilar trastuzumab co-developed by Mylan and Biocon, in comparison to branded trastuzumab. The results of the trial were first presented at this year's American Society of Clinical Oncology (ASCO) Annual Meeting and the European Society for Medical Oncology (ESMO) Congress.

Branded trastuzumab is indicated to treat certain HER2-positive breast and gastric cancers.

"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," said Dr. Narendra Chirmule, Sr. Vice President & Head R&D, Biocon.

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-14010 compared to 64% 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."

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-14010, could provide an effective treatment option for metastatic breast cancer patients. Phase 3 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. Welook forward to continuing our industry-leading role with Biocon toexpand 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."

The HERITAGE data was submitted by Mylan to the U.S. Food and Drug Administration (FDA).