Samsung Bioepis Receives EU Marketing Authorization For Trastuzumab Biosimilar

Samsung Bioepis announced today that the European Commission (EC) has granted marketing authorization for Ontruzant®, a biosimilar for Herceptin® (trastuzumab), across all 28 European Union member states and the European Economic Area member states of Norway, Iceland and Liechtenstein. According to the press release, Ontruzuant® is approved for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer.  Samsung Bioepis stated that ONTRUZANT® will be commercialized by MSD, which is known as Merck in the United States and Canada.

Samsung Bioepis reports that this is its fourth biosimilar to receive EC marketing authorization, and the first trastuzumab biosimilar to receive regulatory approval in Europe.