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Pharmaceuticals / Submissions and Approvals

Samsung Bioepis Gets EC Clearance for Herceptin Biosimilar

Nov. 27, 2017

The European Commission granted a marketing authorization to Samsung Bioepis’ biosimilar for Genentech’s cancer drug Herceptin (trastuzumab).

The drug, Ontruzant, is the first trastuzumab biosimilar cleared for marketing in Europe. The approval applies to all 28 European Union members.

Ontruzant is the fourth Samsung Bioepis biosimilar to secure EC authorization following Benapali, Flixabi and Imraldi.

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