Journal of the American Medical Association (JAMA) publishes Mylan and Biocon’s proposed biosimilar trastuzumab Phase 3 data.
Mylan N.V. and Biocon Ltd. 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-1401O, 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 HERITAGE data was submitted by Mylan to the U.S. Food and Drug Administration (FDA) as part of the biologics license application (BLA) for MYL-1401O last month.
“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, commented. “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.”
Rugo is an independent consultant for Mylan. She serves as the chair of the steering committee for the HERITAGE study and does not receive compensation from Mylan.
“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,” Rajiv Malik, Mylan president, added. “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. 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.”
Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products. The proposed biosimilar trastuzumab is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights for the proposed biosimilar trastuzumab in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.
For the full biosimilar trastuzumab study, click: “Effect of a Proposed Trastuzumab Biosimilar Compared With Trastuzumab on Overall Response Rate in Patients With ERBB2 (HER2)-Positive Metastatic Breast Cancer: A Randomized Clinical Trial.”
(Source: PR Newswire)
Filed Under: Drug Discovery