Samsung Bioepis Secures FDA Approval for High-Cost Rare Disease Drug in the U.S.

Samsung Bioepis announced on the 23rd that it has received approval from the U.S. Food and Drug Administration (FDA) for 'Epysqli' (active ingredient: Eculizumab), a high-cost treatment for rare diseases. Epysqli is a biosimilar of Alexion's 'Soliris'. Samsung Bioepis received approval for Epysqli as a treatment for paroxysmal nocturnal hemoglobinuria (PNH), a condition characterized by the destruction of red blood cells within blood vessels leading to blood clots and dark urine, and atypical hemolytic uremic syndrome (aHUS), a disorder that results in anemia due to the formation of blood clots within blood vessels.

Soliris is known as a high-cost treatment for rare diseases. In the U.S., the annual per-patient treatment cost for PNH and aHUS is approximately $600,000 (about 780 million KRW). This highlights the significant unmet medical need for high-cost biopharmaceuticals in clinical settings.

Last July, the company launched Epysqli in Europe, achieving the top market share for Soliris biosimilars in Germany and Italy. In South Korea, Epysqli was launched in April, offered at roughly half the price of the original medication.

Ko Han-sung, CEO of Samsung Bioepis, stated, "Securing approval for a rare disease treatment in the U.S. acknowledges our global R&D capabilities. Epysqli is a product that can maximize the social value of biosimilars, and we will continue our efforts to realize this value in the world's largest pharmaceutical market, the U.S."

With this approval, Samsung Bioepis now has a total of eight biosimilar products in the U.S. market. The company has also expanded its treatment areas to include blood and kidney diseases, in addition to autoimmune diseases, cancer, and ophthalmic conditions.