Samsung Bioepis announced on the 8th that its treatment for rare intractable diseases, ‘Epysqli (ingredient name eculizumab),’ has been launched in the United States.
Epysqli is a biosimilar (replica of a biopharmaceutical) of ‘Soliris,’ a treatment for rare diseases developed by Alexion in the U.S., including paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and generalized myasthenia gravis (gMG). Last year, the global sales of Soliris amounted to $2.588 billion (Hanwha 3.8 trillion won), with approximately $1.84 trillion won in sales from the United States, accounting for about 60% of total revenue. Epysqli is being launched at a price reduced by 30% from the wholesale acquisition cost (WAC) of Soliris.
Soliris is considered a representative ultra-high-cost biopharmaceutical with low accessibility for patients. It is known that the annual treatment cost for paroxysmal nocturnal hemoglobinuria (PNH) in the United States reaches approximately $520,000 (760 million won).
Samsung Bioepis launched Epysqli in the U.S. through a partnership agreement with Teva Pharmaceutical Industries, signed earlier in January for market entry. The company supplies Epysqli directly in South Korea and Europe. Since its launch in Europe in July 2023, it has achieved the number one market share in the biosimilar markets of Germany and Italy, as well as securing bids from the largest purchasing group in France (UniHA) and from State Governments in the Netherlands.
Samsung Bioepis previously launched Episcli in the U.S. through Teva Pharmaceutical Industries, with whom the company signed a partnership agreement in January to enter the U.S. market. The company is distributing Epysqli in South Korea and Europe through a direct sales system. Since its launch in Europe in July 2023, the company has achieved the number one market share for biosimilars in Germany and Italy, and has won state tenders from France’s largest purchasing union (UniHA) and the Netherlands.
Linda Choi, Deputy Minister of Samsung Bioepis’ Commercial Division, noted, ‘The launch of Epysqli is expected to play a significant role in expanding treatment options for patients suffering from rare diseases in the U.S.’ She also mentioned, ‘We will continue to strive for a sustainable healthcare system by providing biopharmaceuticals at reasonable prices confirmed for quality, safety, and efficacy, and we will collaborate actively with our partner Teva for this purpose.’