Biocon's breast cancer drug clinical data published in JAMA

Moneycontrol BureauBiocon and its partner Mylan on Tuesday announced that the results of the clinical trial study of its biosimilar trastuzumab have been published in the Journal of the American Medical Association (JAMA). This study was the last major step of a multiple-phased programme to demonstrate that the proposed biosimilar trastuzumab meets the criteria for equivalence 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. The JAMA’s publishing provides further credence to Biocon’s trastuzumab biosimilar – that was under review by USFDA for approval.Roche’s subsidiary Genentech is the innovator of the drug that contributed $6.54 billion in global sales for the company in 2015.Biocon partnered with Mylan to develop six biosimilar products, including trastuzumab.A biosimilar is a complex biological product that follows a different approval pathway compared to chemical drugs.“Phase 3 study results show that a biosimilar can deliver similar efficacy in comparison to a branded product,” said Mylan president Rajiv Malik. Shares of Biocon rose 1.33 percent and were trading at Rs 906 at 2.16 pm on Tuesday, the benchmark Sensex gained 0.86 percent and was trading at 26,028.99 points.