Biocon, Mylan get DGCA nod for breast cancer drug

Biocon Ltd said on Tuesday it has won approval from the Drug Controller General of India (DGCA) for marketing a generic version of Roche's Herceptin, used in breast cancer treatment.

The biosimilar Trastuzumab, which the Bangalore-based company said it was jointly developing with US-based Mylan Inc, is expected to be available to Indian patients in the fourth quarter of the current fiscal year (FY14), Biocon said in a statement.

"The Indian approval is an encouraging milepost as we plan to leverage this data to support regulatory filings in several countries across the globe," Biocon chairperson Kiran Mazumdar Shaw said in the statement.

Roche decided not to pursue a patent application for its breast cancer drug Herceptin in India, the Swiss company said in August.

Global sales for Trastuzumab were about $6.4 billion in 2012, including about $21 million in India, Biocon said.

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