Samsung Bioepis gets Korean approval for Soliris biosimilar

Samsung Bioepis, a biosimilar developer under Samsung Group, said Monday that the company's rare blood disease treatment, Epysqli, has won marketing authorization from South Korea's medicine authorities.

Epysqli, a biosimilar close to AstraZeneca's Soliris (eculizumab), is a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare disease where red blood cells prematurely break apart.

Samsung Bioepis expects that the domestic launch of the biosimilar will improve the affordability of patients with the rare disease.

“The latest authorization is significant as it can expand opportunities for domestic rare disease patients to receive treatment at a reasonable price,” said Jung Byoung-in, vice president and regulatory affairs team leader at Samsung Bioepis.

PNH is a debilitating and often fatal disease, but can be treated with medication. The price of Soliris, however, has been very high. An adult patient with PNH is known to spend around $500,000 per year, depending on a patient's weight. This price has limited the treatment's accessibility and availability, according to the company.

In South Korea, the authorization came around 19 months after the company filed its application in June 2022. With the latest approval, Samsung Bioepis will be supplying a total of seven biosimilar products in the country.

In Europe, Samsung Bioepis won marketing authorization from the European Commission (EC) for Epysqli in May last year, based on its phase 3 clinical trial conducted in eight countries between August 2019 and October 2021.

The company has launched the drug in major European countries, including Germany and France.