Mylan Inc has launched the world’s first biosimilar version of breast cancer drug Trastuzumab, in India.
The product, marketed by Mylan under the brand name HertrazTM, is a biosimilar of Roche's Herceptin, Mylan said, without details on how the drug is priced here.
Hertraz is indicated for the treatment of HER2-positive metastatic breast cancer and is available in two strengths, 440 mg and 150 mg.
Biocon is also set to launch its biosimilar version of Trastuzumab this month.
Singling it out as a significant development in its bio-similars programme, Mylan CEO Heather Bresch said, “Mylan is excited to offer Hertraz to thousands of women in India suffering from metastatic breast cancer who are in need of a high quality, more affordable treatment option.”
Mylan President Rajiv Malik added: “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.”
Hertraz was approved by the Drug Controller General of India. In support of this approval, Mylan conducted an extensive series of physicochemical and functional assays to demonstrate similarity to the reference brand Herceptin, the note said. 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.
Trastuzumab is one of the five biologic products Mylan is developing in partnership with Biocon for the global marketplace. Mylan has exclusive commercialisation rights for biosimilar Trastuzumab in the US, Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries and co-exclusive commercialization rights with Biocon for the product in India.
Trastuzumab sales in India are pegged at approximately $21 million for the 12 months ended December 31, 2012.