Wednesday, 19 December 2018



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Product approval in European Union | Biocon, in a filing to exchanges, has said that Ogivri, a biosimilar Trastuzumab has been approved in the European Union (EU). The biosimilar is jointly developed by Biocon and Mylan. 

“The European Commission has granted Marketing Authorization for Ogivri to our 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,” the company said in the statement. 


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

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