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This rendered image shows Samsung Bioepis' headquarters office in Incheon, west of Seoul. (Yonhap)

outh Korean biopharmaceutical firm Samsung Bioepis Co. was in the process of acquiring regulatory approval from European and South Korean drug authorities for SB12, a paroxysmal nocturnal hemoglobinuria (PNH) treatment biosimilar candidate, industry sources said Wednesday.

The company has submitted approval applications for SB12, a more affordable version of Soliris, a drug originally developed by U.S.-based Alexion Pharmaceuticals Inc., with the European Medicines Agency (EMA) and the Ministry of Food and Drug Safety of South Korea.

The EMA has reportedly completed a preliminary review and plans to proceed with the main review on whether to allow commercial use of SB12, the seventh biosimilar developed by Samsung Bioepis.

PNH is a disease in which the destruction of red blood cells leads to red discoloration of the urine. Being a rare disease, there are only approximately 750 patients in South Korea.

Samsung Bioepis was established in 2012 as a joint venture between Samsung Biologics Co., a leading contract development and manufacturing organization, and Biogen Inc. of the United States.

The companies later struck a $2.3-billion stake purchase deal for the company to be wholly owned by Samsung Biologics, a biopharmaceutical unit of South Korea's top conglomerate Samsung Group. (Yonhap)