Mylan-Biocon Gains First Biosimilar Approval

Herceptin biosimilar Trastuzumab to be marketed in India

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Mylan’s partner Biocon has received approval for trastuzumab from the Drug Controller General of India, marking the companies’ first regulatory approval for a Mylan-Biocon developed biosimilar product. Trastuzumaba is biosimilar to Roche’s Herceptin, indicated for the treatment of HER2 overexpressing breast cancer. Mylan plans to market trastuzumab under the trade name Hertraz. Trastuzumab is one of the five biologic products Mylan is developing in partnership with Biocon. Mylan ha...

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