Mylan and Biocon’s proposed biosimilar trastuzumab phase 3 data published in JAMA

Heritage study results demonstrate equivalent overall response rate for MYL-1401O in comparison to branded trastuzumab

Mylan and Biocon recently 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.

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 programme 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 per cent for MYL-1401O compared to 64 per cent 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.”