Samsung Bioepis wins Korean approval for Soliris biosimilar

Samsung Bioepis office building [Courtesy of Samsung Bioepis]

Samsung Bioepis Co., a biopharmaceutical research and development unit under South Korea’s Samsung Group, announced on Monday that it obtained product approval from the country’s Ministry of Food and Drug Safety for its blood disorder treatment ‘SB12’ (Episcli).

SB12 is a biosimilar of Soliris, a drug originally developed by U.S.-based Alexion Pharmaceuticals Inc. to treat intractable rare diseases such as paroxysmal nocturnal hemoglobinuria.

Soliris is a high-priced medication in Korea, with annual medical expenses totaling up to 400 million won ($299,343) for adults. With this approval, the company has now seven biosimilars approved in the country.

“Episcli is a product that aligns with the intrinsic value of developing biosimilars, which is to improve patient access to high-quality medicines,” Jeong Byeong-in, head of Samsung Bioepis’ Regulatory Affairs (RA) Team, said. “This approval is significant in that it expands the opportunity for patients with rare diseases in Korea to receive treatment at an affordable price.”

The indication for Soliris is nocturnal hemoglobinuria, a condition that causes the destruction of red blood cells within blood vessels, leading to symptoms of blood-colored urine and complications such as acute renal failure.