"We have received market authorisation from the Drugs Controller General of India (DCGI) for our biosimilar Trastuzumab developed with Mylan for the treatment of metastatic breast cancer," the city-based company said in a statement Tuesday.
The approval makes the drug the world's first biosimilar version of Herceptin to be marketed in the country under its brand Canmab for breast cancer patients in the next four months.
"The approval is a milestone for both partners as it is the world's first biosimilar Trastuzumab to be marketed. We plan to make the drug available for Indian patients in the fourth quarter of this fiscal (2013-14)," Biocon chairperson Kiran Mazumdar Shaw said in the statement.
Breast cancer is one of the most common types of cancer in India, with over 100,000 new patients being diagnosed with this disease every year. The cost of biologics in cancer treatment is high, which makes access unaffordable to a large patient pool.
"Biosimilar Trastuzumab will offer an alternative affordable option thereby enhancing access to treatment for cancer patients in India and the world over," Shaw said.
The development of the drug involved product characterisation and clinical trains to demonstrate comparability and similarity in pharmacokinetic, safety, efficacy and immunogenicity.
Sales of the drug the world over posted $6.4 billion in 2012 and $21 million in India.
Both the partners have been co-developing the biosimilar monoclonal antibodies and complex biologics since 2009.