Samsung Bioepis has become the first company to secure Europe’s backing of its copy of Roche’s blockbuster breast cancer therapy Herceptin, marking a milestone for the South Korean drugmaker, which specializes in making cheaper copies of complex biologic drugs known as biosimilars.

The European Medicines Agency’s Committee for Medicinal Products for Human Use on Friday recommended the approval of Samsung’s Herceptin-referencing biosimilar Ontruzant. It is the first biosimilar copy of Herceptin to obtain such backing in Europe.

According to protocol, the European Commission is set to follow the EMA’s opinion by issuing marketing approval in around two to three months, upon which Samsung Bioepis can begin selling Ontruzant in European markets. Samsung’s partner Merck & Co. is set to take charge of the drug’s marketing.

The EMA’s endorsement sets Samsung Bioepis on track to bringing the first biosimilar version of Herceptin (trastuzumab) to Europe and challenging sales of Herceptin, which generated around $6.8 billion in global revenue for Roche in 2016.

“We are proud to see Ontruzant become the first trastuzumab biosimilar recommended for approval in Europe, where breast cancer remains the most common form of cancer affecting women,” said Samsung Bioepis CEO Ko Han-sung.

“If approved, we hope Ontruzant will play an important role in expanding patient access to trastuzumab across the region,” Ko said.

Samsung Bioepis is closely being followed by competitors, including Korea’s Celltrion, Mylan and Biocon and Amgen and Allergan which have each submitted their own Herceptin copy for approval by the EMA.

The EMA’s backing of Ontruzant also signals a new feat for Samsung Bioepis’ drug pipeline, as it is the firm’s first cancer-targeting drug to be close to regulatory approval.

Samsung has so far secured approval for three biosimilar drugs in Europe, referencing Remicade, Enbrel and Humira. They are all anti-TNF therapies targeting autoimmune diseases such as rheumatoid arthritis and Crohn’s disease.

Friday’s development also led local analysts to raise their target stock price for Samsung BioLogics, the parent company of Samsung Bioepis, on Monday. Shares of Samsung BioLogics hit an all-time high of 333,500 won ($300) before closing at 328,500 won on the day, up 0.61 percent from the previous trading day.

Samsung Bioepis was founded in 2012 as a joint venture between contract drug manufacturer Samsung BioLogics and US drugmaker Biogen. Biogen holds a 5.4 percent stake in Bioepis, while Samsung BioLogics owns the remainder of the shares.

By Sohn Ji-young (jys@heraldcorp.com)