India set to be the battleground for biosimilars

Likely to be first to market with biosimilar version of trastuzumab

India is set to be the new battleground for off-patent biotech drugs. With the patents for several biologics set to expire in the next couple of years, the country appears to have gone into patenting overdrive. 

With breast cancer therapy Herceptin set to come to the end of its patent protection in 2014 in Europe and in 2019 in the US, competing therapies are in development in the US States and China, but an Indian company has already got the green signal to sell the drug.

Indian biotech major Biocon has received approval from the the Drugs Controller General of India to sell a biological copy of Herceptin. The biosimilar trastuzumab was developed jointly by Biocon and US generics company Mylan and is expected to go on sale in India by the fourth quarter of fiscal year 2014.

Trastuzumab, a medicine originally developed and patented by Swiss drug maker Roche, is sold in world markets, including India, under the brand name Herceptin. The Indian regulator's approval comes three months after Roche relinquished its Indian patent on on the drug.

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