HERITAGE study of Hertraz (trastuzumab biosimilar) in breast and gastric cancer published in JAMA- Mylan and Biocon

Mylan and Biocon announced that the results of the HERITAGE study of Hertraz (trastuzumab biosimilar) in breast and gastric cancer have been published in the Journal of the American Medical Association (JAMA). Study results confirm the efficacy, safety and immunogenicity of proposed biosimilar trastuzumab (MYL 1401O) 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. 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.

See: "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" Hope S. Rugo et al. JAMA. Published online December 1, 2016. doi:10.1001/jama.2016.18305