Samsung Bioepis, a subsidiary of Samsung Biologics, said it has received product approval from the Ministry of Food and Drug Safety for Epiruscly, a biosimilar referencing Soliris, last Friday.

Soliris, developed by AstraZeneca's subsidiary Alexion Pharmaceuticals, is a high-cost biopharmaceutical for the treatment of rare hematological disorders.

As of 2022, the drug generated global sales of approximately 5 trillion won ($3.76 billion). The global rights to Soliris are currently held by AstraZeneca, which acquired Alexion in 2020.

The indications for Soliris include paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and neuromyelitis optica spectrum disorder (NMOSD). The ministry granted approval for Epiruscly to treat only PNH and aHUS.

As of January 2024, the cost of Soliris in Korea is 5,132,364 won per vial (0.3g/30ml), with the annual prescription cost for an adult patient being approximately 400 million won.

“Soliris represents a high-cost biopharmaceutical, with annual medical expenses amounting to several hundred million won per adult patient,” a Samsung Bioepis official said. “We are the only Korean company that has completed global clinical trials and obtained product approval for a biosimilar of Soliris in Korea.”

Samsung Bioepis had also already secured approval for Epiruscly in Europe in May of last year. Subsequently, the company has launched the product in various European markets, including Germany and France, through a direct sales model without partnering with other companies.

“Epiruscly with the core value of biosimilar development, which is to improve patient access to high-quality medicines,” Samsung Bioepis Regulatory Affairs Vice President Jung Byoung-in said. “This approval is significant as it expands treatment opportunities for patients with rare diseases in Korea at a reasonable cost.”