Samsung Bioepis releases Soliris biosimilar in Europe

Samsung Bioepis Co., a biopharmaceutical research and development unit under South Korea's Samsung Group, is rolling out its latest product Epysqli, which references Alexion Pharmaceuticals Inc.’s rare blood disease medicine, Soliris.

According to the pharmaceutical and biotech industry on Thursday, after launching Epysqli in Germany in July, Samsung Bioepis introduced the product in Italy and Spain in September. 

The company received product approval for Epysgqli from the European Commission (EC) in May. Currently, it is selling Epysqli through a direct sales system without a partner company and plans to launch it in France and the Netherlands this year.

Epysqli, the company's first biopharmaceutical in the field of hematology, is a biosimilar of Soliris, a treatment for paroxysmal nocturnal hemoglobinuria (PNH) developed by the US pharmaceutical company Alexion.

PNH is a condition in which red blood cells are destroyed within the vessels, causing blood clots and hemolytic events at night, leading to dark urine. Severe cases can be fatal.

Administering Soliris allows patients with this condition to have a lifespan similar to the general population. However, with an annual cost of 400 to 500 million won ($294,681~$368,351), the development of a biosimilar was urgently needed.

Despite challenges, mainly due to the rarity of the condition, Samsung Bioepis managed to orchestrate Phase 3 clinical trials from August 2019 to October 2021. Spanning roughly two years and involving participants from eight nations, these trials successfully established Epysqli's equivalency.

Write to Dae-Kyu Ahn at powerzanic@hankyung.com