Samsung Bioepis’ Herceptin biosimilar received final European approval
Samsung Bioepis Co., Ltd. announced the European Commission’s (EC) marketing authorization of Ontruzant, a biosimilar referencing Herceptin (trastuzumab), for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer.
Ontruzant is the first trastuzumab biosimilar to receive regulatory approval in Europe.
The EC approval of Ontruzant applies to all 28 European Union (EU) member states and the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein. Ontruzant will be commercialized by MSD, which is known as Merck in the United States and Canada.
Ontruzant is the fourth biosimilar developed by Samsung Bioepis to receive EC marketing authorization. Samsung Bioepis has also received marketing authorizations for Benepali (etanercept), Flixabi (infliximab) and Imraldi (adalimumab).
Source: Samsung Bioepis press release