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Samsung Bioepis' Ontruzant becomes first Herceptin biosimilar approved in Europe

04:32 EST 20 Nov 2017 | Pharmafile

Samsung Bioepis has announced that Ontruzant, the company’s biosimilar version of Roche’s Herceptin, has been awarded marketing authorisation in Europe by the EMA for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer.

The authorisation covers all 28 EU member states in addition to Norway, Liechenstein and Iceland and marks the fourth biosimilar from the company to be approved in the region. Samsung Bioepis has already secured approval for biosimilar versions of Humira, Remicade and Enbrel.

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Original Article: Samsung Bioepis' Ontruzant becomes first Herceptin biosimilar approved in Europe

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