Samsung Bioepis launches Soliris biosimilar in Europe

Samsung Bioepis, a biosimilar developer under Samsung Group, said Thursday that the company has completed the launches of its hematology biosimilar Epysqli, a biosimilar close to Soliris, in three European countries, hoping to gain ground in the rare blood disease biosimilar market.

According to Samsung Bioepis, the company introduced Epysqli in Germany in July, and the biosimilar made its debut in Italy and Spain last month.

Samsung Bioepis is also preparing for Epysqli’s launch in France and the Netherlands within the year, the company said, adding that it is not planning on launching the biosimilar in other European countries beyond that.

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

PNH is a debilitating and often fatal disease, but can be treated with medication. However, the price of Soliris is around $500,000 per patient, per year, depending on a patient's weight. This price limits the treatment's accessibility and availability.

Soliris was originally developed by US-based Alexion Pharmaceuticals. But the rights to Soliris are currently owned by AsztraZeneca, which completed the acquisition of Alexion Pharmaceuticals in 2021.

“Samsung Bioepis is pleased that the company can increase the availability of the medication through its launches in Europe. The company will continue its efforts and contribute to unmet medical needs,” Samsung Bioepis said.

Samsung Bioepis’ Epysqli received marketing authorization from the European Commission in May, based on its phase 3 clinical trial conducted in eight countries between August 2019 and October 2021.

Adding Epysqli to its portfolio, Samsung Bioepis currently has seven biosimilars approved for use in Europe, including Benepali, an anti-inflammatory biosimilar close to Enbrel, and Imraldi, a biosimilar close to Humira.