Samsung Bioepis Secures FDA Approval for High-Cost Rare Disease Drug in the U.S.
Soliris Biosimilar 'Epysqli'... Total of 8 FDA-Approved Products
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.