Samsung Bioepis announced on the 12th that it has signed a commercialization partnership agreement with Teva Pharmaceutical Industries to enter the U.S. market with the rare disease treatment "Epysqli."
Under this agreement, Samsung Bioepis will be responsible for product production and supply as the developer of Epysqli, while Teva will handle marketing and sales activities in the United States.
Epysqli (generic name eculizumab) is a biosimilar to the rare disease treatment "Soliris" developed by Alexion in the United States. Samsung Bioepis obtained approval for Epysqli from the U.S. Food and Drug Administration (FDA) last July for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Subsequently, in November of that year, it expanded the indication to generalized myasthenia gravis (gMG) through additional FDA approval.
"Soliris" is a representative ultra-expensive biopharmaceutical with significant unmet needs in the medical field. It is reported that the average annual cost of treatment for PNH in the U.S. is about $520,000 (approximately 760 million won).
Kim Kyung-ah, CEO of Samsung Bioepis, said, "Epysqli is a drug that can best realize the essential meaning of biosimilar development by expanding access to ultra-expensive biopharmaceuticals," adding, "We will work closely with Teva to focus on improving the lives of patients suffering from rare diseases in the U.S. market."
Chris Fox, Vice President of U.S. Commercial at Teva, noted, "We will work with Samsung Bioepis to utilize our commercial capabilities to expand treatment accessibility."
Meanwhile, Samsung Bioepis has been supplying Epysqli to the medical field through a direct sales system in Europe and Korea. In Europe, it launched in July 2023, achieving the top market share in the biosimilar market in Germany and Italy, and securing bids from the largest purchasing group in France (UniHA) and State Governments in the Netherlands. In Korea, it received praise for launching its product at about half the price compared to existing original medicines last April, thereby increasing patient accessibility to ultra-expensive biopharmaceuticals.