Mylan Receives Approval for Biosimilar in India; Reaches Settlement with Teva on Copaxone

The generic-drug/specialty pharmaceutical company Mylan and the Indian biopharmaceutical company Biocon have received approval for a biosimilar version of trastuzumab in India. The product is a biosimilar to Roche's Herceptin, indicated for the treatment of HER2 overexpressing breast cancer. Mylan intends to market its trastuzumab product under the trade name Hertraz.

Trastuzumab is one of five biologic products Mylan is developing in partnership with Biocon. Mylan has exclusive commercialization rights for biosimilar trastuzumab in the United States, Canada, Japan, Australia, New Zealand, and countries in the European Union and European Free Trade Association and co-exclusive commercialization rights with Biocon for the product in India. Mylan expects to launch trastuzumab in India early in 2014.

In other news, Mylan reports that it and Teva Pharmaceutical Industries have agreed to settle and dismiss pending patent litigation involving Teva's e multiple-sclerosis drug Copaxone (glatiramer acetate) in the United Kingdom, the Netherlands, and France relating to noninfringement and the validity of European Patent 0,762,888, which expires in May 2015. The terms of the settlement are confidential.

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Mylan

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Teva Pharmaceutical Industries