Ontruzant is a biosimilar referencing Herceptin (trastuzumab) that can be used to treat patients with early breast cancer, metastatic breast cancer and metastatic gastric cancer.
The Samsung Bioepis therapy is the first trastuzumab biosimilar to receive regulatory approval in Europe.
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.
The drug will be commercialised by US-based company Merck, which is known as Merck Sharp & Dohme (MSD) outside the US and Canada.
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.”
The treatment is the fourth biosimilar developed by the biopharmaceutical company to receive EC marketing authorisation.
Samsung Bioepis has also received marketing authorisations for Benepali (etanercept), Flixabi (infliximab) and Imraldi (adalimumab).
Samsung Bioepis is a joint venture (JV) between Samsung BioLogics and Biogen.