This is the first approval for a biosimilar product developed by Biocon and Mylan, which joined the project in 2009. The product is a biosimilar to Swiss pharma giant Roche’s Herceptin, used for the treatment of this type of breast cancer. Biocon and Mylan will sell products under CANMAb and Hertraz brand, respectively. Biosimilars are independently developed follow-on versions of medicines after their patent has expired.
“Biocon and Mylan with this approval will be selling the product to expand the market base even though we will be selling under different brands. There is a huge demand for this product and with our biosimilar, we will be pricing our product pretty aggressively as against the existing innovator product,” Kiran Mazumdar-Shaw, chairman and managing director, Biocon, told Business Standard.
In the past quarter, Biocon rolled out its first biologic drug (made in a living system such as a microorganism, plant or animal cells), ALZUMAb, for the treatment of psoriasis skin disease.
The Indian market for the anti-breast cancer drug is worth around Rs 300 crore and apart from Roche itself, India’s Emcure sells Roche’s product in the country. A normal course costs around Rs 75,000. Earlier this year, Roche chose not to pursue an Indian patent for its drug, throwing open the market for Indian generic makers. Roche has already embarked on the next-generation innovator drug for this disease.
The Union government had earlier decided to issue compulsory licences to three patented cancer drugs in India — trastuzumab, ixabepilone (used for chemotherapy in breast-cancer treatment) and dasatinib (for leukaemia), after Hyderabad-based Natco Pharma was given a compulsory licence to make the generic version of German Bayer’s patent-protected anti-cancer drug Nexavar last year.
Mylan Chief Executive Heather Bresch said: "This regulatory achievement marks another Mylan first and underscores our commitment to, and confidence in, our biologic development program with Biocon and our belief that these products will become a global growth driver for Mylan over the long-term. We expect to launch our trastuzumab product in India early next year, marking our first launch of a biologic. This launch also further strengthens our expanding commercial presence in India, as we enter the oncology and critical care segments."
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, the European Union and the European Free Trade Association countries, and commercialisation rights with Biocon in India.
Breast cancer is one of the most common types of cancer in India with over 100,000 new patients being diagnosed every year. The cost of biologics in cancer treatment is extremely high.
Mazumdar-Shaw said the development of the cancer drug involved extensive product characterisation and clinical trials to demonstrate comparability and similarity in pharmacokinetic (or the study of the action of drugs in the body, method and rate of excretion; duration of effect, etc), safety, efficacy and immunogenicity (the property of eliciting an immune response) against the innovator product.
"We are committed to affordable cancer care and believe that biosimilar trastuzumab will expand patient access to this life saving drug. The Indian approval is an encouraging milepost as we plan to leverage this data to support regulatory filings in several countries across the globe," she said.
The Biocon share gained 0.12 per cent to close at Rs 372.05 apiece on the BSE exchange.