Samsung Bioepis said that the European Commission (EC) has granted marketing authorization for Epysqli, a biosimilar referencing Soliris (ingredient: eculizumab) for the treatment of adult and children patients with paroxysmal nocturnal hemoglobinuria (PNH).

Soliris is a drug developed by Alexion, a U.S.-based pharmaceutical company, for the treatment of rare intractable diseases such as PNH. The drug recorded global sales of approximately $5 trillion last year.

Epysqli is the first hematology biosimilar developed by Samsung Bioepis, and its final marketing authorization comes nearly two months after the company received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) on March 30.

According to the company, the EC approval is based on a totality of evidence, including analytical, in vitro non-clinical data, and clinical data.

A randomized, double-blind, multicenter, cross-over phase 3 study of Epysqli demonstrated equivalent clinical efficacy of the biosimilar compared to Soliris after evaluating lactate dehydrogenase (LDH) in PNH patients.

“Epysqli has demonstrated equivalence through comparative trials with original medicines and is expected to contribute to addressing unmet needs by improving patient access to ultra-high cost medicines,” said Jang Jun-ho, the principal investigator of Epysqli's phase 3 clinical trial and a Professor of the Department of Hemato-oncology at Samsung Medical Center,

Samsung Bioepis Vice President and Regulatory Affairs Team Leader Jung Byoung-in also said, “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, Jung added.