Hyderabad: Mylan NV and Biocon Ltd on Saturday said its proposed trastuzumab biosimilar drug MYL-1401O was found to be comparable to innovator Roche Holding AG’s Herceptin at treating advanced, HER2 positive breast cancer pertaining to both efficacy and safety.

The finding came in a phase-III study that rolled out on Friday at the American Society of Clinical Oncology (ASCO) annual meeting at Chicago.

The phase-III study or HERITAGE study—showed that MYL-1401O had equivalent efficacy and safety to trastuzumab, and that it does not trigger an immune response (low immunogenicity).

The objective response rates at 24 weeks were 69.6% with MYL-1401O vs 64% with trastuzumab.

“(The) difference in overall response fell within a narrow, pre-defined equivalence margin suggesting equal efficacy of both products," said Dr. Hope S. Rugo, professor of Medicine at the University of California, San Francisco.

“The immunogenicity and safety were comparable between treatment groups," Rugo added.

The rates of serious adverse events were 36% in the trastuzumab group and 38% in the MYL-1401O group, according to the study.

The most common serious side effect was low blood counts (neutropenia), and there was no difference in measures of cardiac function between the two arms.

A biosimilar product is a complex biological product that follows a different approval pathway compared to chemical drugs. Biosimilars involve clinically testing the drug on animals and humans to demonstrate that the drug is highly similar to the innovator biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product.

Roche’s subsidiary Genentech Inc. is the innovator of monoclonal antibody trastuzumab, which is used primarily in the treatment of HER 2 positive breast cancer.

Herceptin had contributed $6.54 billion in global sales for Roche in 2015.

The positive phase-III data will come in hand for Mylan and its partner Biocon when filing for regulatory approvals. Biocon has indicated that it will start filing a number of regulatory submissions in the US and Europe for many of its biosimilar programs in fiscal year 2017.

Biocon and Mylan market ‘CANMAb’ and ‘HERTRAZ’ as biosimilars of Herceptin in India. In 2009, Biocon partnered with Mylan to develop six biosimilar products, including trastuzumab.

Biocon launched CANMAb in 2014, and sells at 25% cheaper rates than innovator Roche’s Herceptin at 75,000 per 400 mg goal.

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

“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 program," said Rajiv Malik, president, Mylan.

“The trial will enable regulatory filings of our product in the developed markets," said Kiran Mazumdar Shaw, said chairperson and managing director of Biocon.

Worldwide, nearly 2 million women are diagnosed with breast cancer each year, 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% to 30% of primary breast cancers are HER2-positive.

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