SEOUL, Nov. 20 (Korea Bizwire) — South Korean biopharmaceutical firm Samsung Bioepis Co. said Monday it has won approval from European authorities for the sale of its biosimilar drug Ontruzant.
The European Commission (EC) accepted Samsung Bioepis’ application to sell the biosimilar referencing Switzerland-based Roche Holding’s Herceptin, also known as Trastuzumab, the company said. The drug is designed to treat early breast cancer, metastatic breast cancer and metastatic gastric cancer.
With the approval, Ontruzant can be sold in 28 EU member states as well as Norway, Iceland and Liechtenstein, according to the company.
With the marketing authorization of Ontruzant, Samsung BIoepis became the first player to receive European approval for the biosimilar referencing Herceptin.
“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,” said Christopher Hansung Ko, CEO of Samsung Bioepis, in a press release.
The approval comes two months after the European Medicines Agency adopted a positive opinion on Ontruzant.
Samsung Bioepis said it has set an industry record by obtaining European regulatory approval for four biosimilars — the others being Benepali, Flixabi and Imraldi — in just two years
Samsung Bioepis was established in 2012 in a joint venture between Samsung Biologics and Biogen Inc. Samsung BioLogics is a biopharmaceutical unit of South Korea’s top conglomerate, Samsung Group.
The market for biosimilars has grown in recent years as they are provided to customers at discounts. Biosimilars are officially approved copycat medicines developed after patents for the original biopharmaceuticals expire.