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Biocon-Mylan’s Biosimilar of Herceptin approved in India

Biocon, India’s largest listed biotechnology company, informed it had received marketing authorisation from the Drugs Controller General of India (DCGI) for its trastuzumab biosimilar, being developed jointly with US’ Mylan, for the treatment of HER2+ metastatic breast cancer. The product will be launched during the last quarter of this financial year.

This is the first approval for a biosimilar product developed by Biocon and Mylan, which joined the project in 2009. The product is a biosimilar to Swiss pharma giant Roche’s Herceptin, used for the treatment of this type of breast cancer. Biocon and Mylan will sell products under CANMAb and Hertraz brand, respectively. Biosimilars are independently developed follow-on versions of medicines after their patent has expired.