Samsung Bioepis Receives EC Clearance for First Trastuzumab Biosimilar
A Korean-based biopharmaceutical company, Samsung Bioepis, has now announced the European Commission’s marketing authorization of Ontruzant, a biosimilar referencing Herceptin (trastuzumab), for the treatment of early breast cancer, metastatic breast cancer, and metastatic gastric cancer.
Samsung Bioepis is a joint venture (JV) between Samsung BioLogics and Biogen. The company is the first trastuzumab biosimilar to receive regulatory approval in Europe. The drug will be commercialized by the US-based company Merck, which is known as Merck Sharp & Dohme (MSD) outside the US and Canada.
The current approval of the cancer treatment is applicable for all 28 European Union (EU) member states, in addition to the member states of the European Economic Area (EEA), including Norway, Iceland, and Liechtenstein.
Samsung Bioepis president and chief executive officer Christopher Hansung Ko said: “Breast cancer remains the most common form of cancer affecting women. We hope Ontruzant will play an important role expanding patient access to trastuzumab across the region. Through relentless process innovation and an uncompromising commitment to quality, we remain dedicated to advancing one of the industry’s strongest biosimilar pipelines, so that more cancer patients and healthcare systems across Europe will benefit from biosimilars.”
