Samsung's Ontruzant Becomes First Trastuzumab Biosimilar Approved In EU

Samsung Bioepis is poised to grab the leading position in the trastuzumab biosimilar market in Europe as its biosimilar Ontruzant gets the European Commission's approval ahead of the competition.

Samsung Bioepis
Samsung Bioepis researchers conducting a study • Source: Samsung Bioepis

Samsung Bioepis Co. Ltd. 's Ontruzant, a biosimilar version of Roche 's Herceptin (trastuzumab), has become the first trastuzumab biosimilar to get the green light from the European Commission, beating rival products also going through the regulatory approval process in Europe.

Celltrion Inc. also has a biosimilar trastuzumab, Herzuma, under review in the EU, and could be the next to secure a positive opinion the European Medicines Agency, having submitted its dossier at the same time as Samsung Bioepis. Other companies developing biosimilar versions include Pfizer Inc

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