Biocon along with Mylan will present data from the HERITAGE study at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, June 3-7. The study confirmed the efficacy, safety and immunogenicity of MYL-1401O, the proposed biosimilar trastuzumab co-developed by Biocon and Mylan, in comparison to branded trastuzumab.
 
“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,” said Rajiv Malik, president, Mylan.
 
Kiran Mazumdar Shaw, chairperson and managing director, Biocon, said that 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 program with Mylan. The trial will enable regulatory filings of our product in the developed markets.
 
Worldwide, nearly 2 million women are diagnosed with breast cancer annually, making it the second most common cancer in the world. HER2-positive metastatic breast cancer is an aggressive form of breast cancer that tests positive for the human epidermal growth factor receptor 2 (HER2), which promotes cancer cell growth. Approximately 20 per cent to 30 per cent of primary breast cancers are HER2-positive. Trastuzumab is indicated for the treatment of HER2-positive metastatic breast cancer patients.
 
Heritage is a double-blind, randomized clinical trial designed to evaluate comparative efficacy and safety of the proposed trastuzumab biosimilar, MYL-1401O, versus branded trastuzumab. Eligible patients had centrally confirmed, measurable HER2-positive metastatic breast cancer without prior chemotherapy or trastuzumab for metastatic disease. Patients were randomized to receive either MYL-1401O or branded trastuzumab with docetaxel or paclitaxel for a minimum of eight cycles.
 
“The Heritage  study successfully met the predefined endpoints of response equivalency. It puts us one step closer to approval of this proposed biosimilar. The response rates at 24 weeks were 69.6 per cent with MYL-1401O combined with taxane chemotherapy versus 64 per cent with branded trastuzumab combined with the same chemotherapy agent. The ratio of overall response and difference in overall response fell within a narrow, pre-defined equivalence margin suggesting equal efficacy of both products. Safety was comparable between treatment groups. The rates of serious adverse events were 38 per cent with MYL-1401O and 36 per cent with branded trastuzumab, and there was no difference in cardiac safety,” commented lead study author Dr. Hope S. Rugo, professor of Medicine, University of California, San Francisco.

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. While Mylan has exclusive commercialisation rights for the proposed biosimilar trastuzumab in US, Canada, Japan, Australia, New Zealand EU and European Free Trade Association countries, Biocon has co-exclusive commercialisation rights with Mylan for the product in the rest of the world.