Mylan Inc. through its subsidiary, Mylan Pharmaceuticals Private Limited, is offering the Indian market trastuzumab biosimilar in India. The product, sold under the brand name Hertraz, is the biosimilar version of Roche's Herceptin.
Hertraz is indicated for the treatment of HER2-positive metastatic breast cancer and is available in two strengths, 440 mg and 150 mg.
Trastuzumab is one of the five biologic products Mylan is developing in partnership with Biocon for the global marketplace. Mylan has exclusive commercialization rights for biosimilar trastuzumab in the US, Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. It has a co-exclusive commercialization right with Biocon for the product in India.
“We now providing 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. 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,” stated Heather Bresch, CEO, Mylan.
According to Rajiv Malik , president, Mylan the launch of Hertraz is of particular significance as it represents both the company’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.
Hertraz was approved by the Drug Controller General of India (DCGI). In support of this approval, the company conducted an extensive series of physicochemical and functional assays to demonstrate similarity to the reference brand Herceptin. These analytical methodologies confirmed the high degree of molecular similarity as well as biological activity of Hertraz.
In addition, Mylan conducted a multi-centre clinical trial to demonstrate comparable safety and efficacy to the reference product.
Currently, Mylan has 187 ANDAs pending FDA approval representing $93.7 billion in annual sales, according to IMS Health. Forty-one of these pending ANDAs are potential first-to-file opportunities, representing $24.1 billion in annual brand sales, for the 12 months ending June 30, 2013, according to IMS Health. When including ANDAs associated with Mylan's recent acquisition of Agila, the company now has a total of 287 ANDAs pending FDA approval.