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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 has exclusive commercialization rights for biosimilar trastuzumab in the U.S., Canada, Japan, Australia, New Zealand and in the EU and European Free Trade Association countries and co-exclusive commercialization rights with Biocon for product in India. Mylan expects to launch trastuzumab in India early in 2014.

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