News Feature | February 4, 2014

Mylan Subsidiary Launches First Trastuzumab Biosimilar Hertraz™ In India

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By Estel Grace Masangkay

Mylan Inc. announced that its subsidiary Mylan Pharmaceuticals Private Limited has launched its breast cancer treatment Hertraz in India. Hertraz is the world’s first trastuzumab biosimilar.

The drug is a biosimilar to Roche’s Herceptin and will be marketed in India in 440mg and 150mg variants. Hertraz is indicated as treatment of HER2-positive metastatic breast cancer. Trastuzumab had estimated sales of $21 million in India last year, according to the IPSOS.

Trastuzumab is only one of the several biologic products the company is developing in collaboration with Biocon. Heather Bresch, Mylan’s chief executive officer, said, “Mylan is excited to offer Hertraz to the thousands of women in India suffering from metastatic breast cancer who are in need of a high quality, more affordable treatment option. The launch of Hertraz not only represents a significant milestone in our biosimilars development program with Biocon, but, more importantly, supports our mission to expand access to high quality medicine around the world and demonstrates our progress against one of Mylan's key future growth drivers.”

The Drug Controller General of India granted approval for Hertraz with support from Mylan through a broad series of physiochemical and functional assays demonstrating efficacy similar to reference product. The company also conducted a multi-center clinical trial to demonstrate safety compared to the reference brand Herceptin.

Rajiv Malik, Mylan’s president, said “The launch of Hertraz is of particular significance as it represents both Mylan's first biosimilar and the world's first trastuzumab biosimilar. We look forward to expanding our portfolio of high quality and affordable biosimilar offerings, particularly in the oncology care segment, in India and around the world in the coming years.”

Mylan holds exclusive rights to market biosimilar trastuzumab in Canada, Japan, the U.S., Australia, New Zealand, and in the European Union and European Free Trade Association countries.