Samsung Bioepis' Epysqli / Courtesy of Samsung Bioepis

The U.S. Food and Drug Administration (FDA) has approved Samsung Bioepis' Epysqli as a biosimilar to Soliris, one of the most expensive drugs used for treating patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).

Samsung Bioepis said Tuesday that its Epysqli gained the FDA's biologics license application, marking the eighth U.S. biosimilar approval for the company.

Samsung Bioepis said the FDA granted the approval as the data demonstrates that Epysqli is highly similar to Soliris, with no clinically meaningful differences between the two in terms of safety, purity and potency.

Soliris, manufactured by Alexion Pharmaceuticals, is one of the most expensive drugs in the United States targeting rare diseases. According to a 2021 survey by market tracker GoodRx Research, Soliris was the 10th most expensive drug, with an annual cost of $678,400 based on the length of therapy.

Samsung Bioepis said approximately 70 percent of Soliris-treated PNH patients are not dosed according to the label, which may be attributed to several factors, including the high treatment cost. Due to this, the company seeks to launch the biosimilar at half the price of its original to improve patients' accessibility to treatments.

"The FDA approval of Epysqli as a biosimilar to Soliris marks an important milestone for PNH and aHUS communities since biosimilars have a potential to positively impact patients and healthcare systems by reducing healthcare costs and improving access to treatments," Samsung Bioepis CEO Ko Han-sung said.

"Our mission has been, and always will be, improving the lives of patients by providing quality-assured, safe and effective biologic medicines, and our work to fulfill this mission is expanding into rare disease areas where patients continue to suffer from limited access to life-enhancing medicines."

Outside the U.S., Samsung Bioepis launched Epysqli in Europe in July of last year and has been selling it in Korea since April.