Mylan, Biocon India confirm efficacy of trastuzumab

 Pharma major Mylan and Biocon have confirmed the efficacy, safety and immunogenicity of MYL-1401O, the proposed biosimilar trastuzumab co-developed by the firms, in comparison to branded trastuzumab.

The companies will present data from a clinical study during the American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago from June 3-7, Biocon said in a statement.

“As one of the first companies in the industry to successfully complete a confirmatory efficacy and safety study comparing a proposed biosimilar to a branded cancer drug, this is a significant milestone for Mylan’s biosimilar programme,” Mylan President Rajiv Malik said.

“There is an urgent, unmet need for more affordable versions of biologic products and through our collaboration with Biocon we are well-positioned to be at the forefront to help deliver these complex products to patients around the world. American Society of Clinical Oncology(ASCO) has recognised the importance of biosimilars in advancing cancer care and the significant role they will play in providing patients greater access to affordable treatment.”

Kiran Mazumdar Shaw, Chairperson and Managing Director, Biocon, said, “The positive outcomes of the global Phase 3 clinical study with our proposed biosimilar trastuzumab for HER2-positive breast cancer patients are a significant milestone in our joint biosimilars development programme with Mylan. The trial will enable regulatory filings of our product in the developed markets.”

She added that Biocon remains committed to develop affordable biologics and these study results will help the company in enhancing access for cancer patients, caregivers and healthcare systems across the globe. Trastuzumab is indicated for the treatment of HER2-positive metastatic breast cancer patients.