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Biocon and Mylan receive DCGI approval for Biosimilar Trastuzumab

26 Nov 2013 Evaluate

Biocon, Asia’s leading biotechnology enterprise, has received marketing authorization from the Drugs Controller General of India (DCGI) for its biosimilar Trastuzumab being developed jointly with Mylan, for the treatment of Her 2+ metastatic breast cancer.

The regulatory approval for biosimilar Trastuzumab in India is an extremely important milestone for Biocon as it is the world's first biosimilar version of Herceptin to be brought to the market. The biosimilar Trastuzumab will be marketed in India under the brand name of CANMAb by Biocon and is expected to be available to Indian patients in Q4 FY14.

Biocon is India’s largest and Asia’s leading Biotechnology Company with a strategic focus on biopharmaceuticals and research services.

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