South Korean drug regulators have approved Samsung Bioepis’ biosimilar drug referencing Roche’s Herceptin, marking the first cancer-fighting biosimilar to be sold by the Songdo-based drugmaker.

Samsung Bioepis announced Thursday that the Korean Ministry of Food and Drug Safety has granted its marketing approval for Samfenet, its biosimilar referencing Roche’s breast cancer treatment Herceptin (trastuzumab).

Samfenet was approved in Korea for the treatment of metastatic breast cancer, early-stage breast cancer and metastatic gastric cancer. The company plans to begin selling the drug in Korea after selecting a marketing partner and completing drug pricing procedures, it said.

Herceptin is among Roche’s topselling biologic drugs. It generated worldwide sales of around $6.78 billion won last year for the Swiss pharmaceutical giant.

Samsung Bioepis has filed its Herceptin biosimilar for regulatory approval in Europe, and is currently awaiting a decision from the European Medicines Agency.

Korea has so far approved three other biosimilars made by Samsung Bioepis, each referencing Enbrel, Remicade and Humira, which are all anti-TNF drugs targeting autoimmune diseases.

Samsung is already selling its biosimilars referencing Enbrel and Remicade in Korea via its local marketing partner Yuhan Corp. It is slated to launch its Humra-referencing biosimilar here after its Korean patent expires in January 2019.

Samsung also sells its Enbrel biosimilar in Europe and its Remicade biosimilar in Europe and the US. Its Humira biosimilar was approved in Europe this year as well.

Headquartered in Songdo of Incheon, Samsung Bioepis specializes in the development of biosimilars, cheaper, near-replicas of biologic drugs whose patents have expired. It was established in 2012 as a joint venture between Samsung BioLogics and US-based Biogen.

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