Biocon, Mylan’s joint product Ogivri gets approval in EU

19 Dec 2018 Evaluate

Biocon and Mylan’s jointly developed product -- Ogivri, a biosimilar Trastuzumab, has been approved in the European Union (EU). The European Commission has granted Marketing Authorization for Ogivri to the company’s partner Mylan.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) previously issued a positive opinion recommending approval of Ogivri as a biosimilar to Roche's Herceptin (Trastuzumab) on October 18, 2018.

Ogivri is indicated for the treatment of patients with HER2 positive early breast cancer (EBC), metastatic breast cancer (MBC) and metastatic gastric cancer (MGC).

Biocon is India’s largest and Asia’s leading Biotechnology Company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation-driven biopharma enterprise offering affordable solutions for chronic diseases to patient's worldwide.

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