Posted by Michael Wonder on 20 Nov 2017
Samsung Bioepis receives regulatory approval for Europe's first trastuzumab biosimilar, Ontruzant
20 November 2017 - Samsung Bioepis sets an industry record by obtaining European regulatory approval for four biosimilars in just two years.
Samsung Bioepis today announced the European Commission’s marketing authorisation 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 member states and the European Economic Area member states of Norway, Iceland and Liechtenstein. Ontruzant will be commercialised by MSD, which is known as Merck in the United States and Canada.
