The European Commission has granted marketing authorization to Samsung Bioepis' biosimilar referencing Soliris (eculizumab). The product, dubbed Epysqli, is the first hematology biosimilar from Samsung Bioepis to be approved in the European Union.
Samsung Bioepis’ Epysqli, an eculizumab biosimilar, was approved in Europe after the European Commission (EC) granted the product marketing authorization. The biosimilar the first approval for a hematology biosimilar developed by the company in the European Union.
Epysqli references Soliris (reference eculizumab) and will be used to treat adult and pediatric patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder that happens when part of the immune system attacks and damages red blood cells and platelets. It is the second eculizumab biosimilar approved in the European Union, following the approval of Amgen's Bekemv (ABP 959).
“The approval of Epysqli, Samsung Bioepis’ first hematology biosimilar, reflects our ongoing endeavors to introduce more treatment options for PNH patients in Europe…. The approval marks another step towards enhancing the lives of patients, including those with rare diseases, through our pioneering and innovative use of science and technology,” said Byoungin Jung, vice president and regulatory affairs team leader at Samsung Bioepis, in a company statement.
The EC approval was based on evidence from analytical, in vitro, nonclinical, and clinical studies. Data from a randomized, double-blind, multicenter, cross-over phase 3 study comparing the effects of Epysqli with the reference product found that the 2 drugs had similar safety, efficacy, pharmacokinetic, pharmacodynamic, and immunogenicity profiles. The results of the analysis were shared at the 2022 European Hematology Association Congress.
The study evaluated the change in lactate dehydrogenase (LDH) levels from baseline in patients with PNH, who were randomized to receive either the biosimilar or reference product (n = 25 patients in each group). Overall, 50 patients with PNH were enrolled in the analysis.
Patients received a 600-mg intravenous dose weekly of the first drug in the treatment group for 4 weeks and 900 mg for the fifth week, followed by 900-mg doses administered every 2 weeks until week 26, when patients were switched to receive the second drug. The patients remained on the second drug until week 50.
In total, 49 patients received treatment with a study drug and 46 completed the full 50 weeks. The mean difference in LDH level measured at week 26 between the biosimilar and the reference product was 34.48 (95% CI, –47.66 to 116.62).
Epysqli is the seventh biosimilar developed by Samsung Bioepis to receive approval for use in Europe following Benepali (etanercept biosimilar; January 2016), Flixabi (infliximab biosimilar; May 2016), Imraldi (adalimumab biosimilar; August 2017), Ontruzant (trastuzumab biosimilar; November 2017), Aybintio (bevacizumab biosimilar; August 2020), and Byooviz (ranibizumab biosimilar; August 2021).
The news comes after the European Medicines Agency’s Committee for Medicinal Products for Human Use gave a positive opinion for Bekemv, another eculizumab biosimilar that was developed by Alexion Pharmaceuticals, in February 2023.
Additionally, Amgen announced in August 2022 that it completed a phase 3 trial for its eculizumab biosimilar candidate, saying that the study met primary end points and confirmed the biosimilarity between the biosimilar and Soliris in patients with PNH.