Samsung Bioepis Receives Approval for First Trastuzumab Biosimilar, Ontruzant, in Europe

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Ontruzant is the first biosimilar of Roche’s Herceptin (trastuzumab) to be approved in Europe.

Samsung Bioepis, a Korean-based biopharmaceutical company, announced on Nov. 20, 2017 that its biosimilar, Ontruzant, which references Roche’s Herceptin (trastuzumab), has received European regulatory approval for the treatment of early breast cancer, metastatic breast cancer, and metastatic gastric cancer. Herceptin is one of Roche’s top-selling drugs with 2016 sales of CHF 6.8 billion (US$6.8 billion) (1).

According to the company, Ontruzant is the first trastuzumab biosimilar approved by the European Medicines Agency for marketing in the 28 European Union (EU) member states and the European Economic Area member states of Norway, Iceland, and Liechtenstein. Ontruzant will be commercialized by MSD, which is known as Merck in the United States and Canada.

“Breast cancer remains the most common form of cancer affecting women. We hope Ontruzan will play an important role expanding patient access to trastuzumab across the region,” said Christopher Hansung Ko, president and CEO of Samsung Bioepis, in a press statement.

Ontruzan is the fourth biosimilar developed by Samsung Bioepis to receive marketing authorization in the EU. Samsung Bioepis has also received marketing authorizations for Benepali (etanercept), Flixabi (infliximab), and Imraldi (adalimumab).


Source: Samsung Bioepis