Biotechnology company Biocon Ltd has got approval from the Drugs Controller General of India to market its biosimilar trastuzumab, developed jointly with US drug-maker Mylan, for treating breast cancer.

The regulatory approval is a key milestone for the company as it is the first biosimilar version of Herceptin to be brought to the Indian market.

The drug is to be marketed in India under the brand name of CANMAb by Biocon.

It is expected to be available to Indian patients in the fourth quarter of the current fiscal.

The global sales of trastuzumab stood at $6.4 billion in 2012, while in India, it recorded $21 million (Rs130 crore today).

Since 2009, Biocon and Mylan have been co-developing a high value portfolio of biosimilar monoclonal antibodies and complex biologics, comprising trastuzumab, pegfilgrastim, bevacizumab, adalimumab and etanercept.

This year, the partnership was extended to co-develop biosimilar insulin analogs for the global markets. The overall global opportunity for biosimilars is estimated at $22 billion by 2020.

“This is a major milestone for both partners as it is the world's first biosimilar trastuzumab to be accorded regulatory approval,” said Kiran Mazumdar-Shaw, Chairperson and Managing Director, Biocon.

“The meticulous development of this important cancer drug has involved extensive product characterisation and clinical trials to demonstrate comparability and similarity in PK (pharmacokinetic), safety, efficacy and immunogenicity 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.”

Breast cancer is one of the most common types of cancer in India, with over one lakh new patients being diagnosed with this disease every year.

The cost of biologics in cancer treatment is high, which makes it unaffordable to a large patient pool.

>anil.u@thehindu.co.in

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