South Korea’s Samsung Bioepis and Israel-based Teva Pharmaceutical (NYSE: TEVA) have entered into a license, development, and commercialization agreement focused on Samsung Bioepis’s EPYLLI, a biosimilar competing with AstraZeneca’s (AZ; NASDAQ: AZN) Soliris (eculizumab) on the US market. Under the partnership, Samsung Bio will be responsible for the development, regulatory registration, manufacture, and supply of the product, while Teva will handle the commercialization of the product in the US. The financial terms of the agreement remain confidential, with no details disclosed.
About Eculizumab and Indications
Eculizumab is a complement inhibitor indicated for the treatment of rare disease patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy, and generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody positive.
EPYLLI Biosimilar Approval and Expansion
EPYLLI was approved in the US as a biosimilar to Soliris in July 2024 for the treatment of patients with PNH to reduce hemolysis, and aHUS to inhibit complement-mediated thrombotic microangiopathy. An indication expansion was secured in the US in November of last year to include AchR antibody positive gMG adult patients. The biosimilar is also registered in the European Union and South Korea, expanding its reach in key markets.
Future Prospects
The partnership between Samsung Bioepis and Teva Pharmaceutical positions both companies to challenge AstraZeneca’s market dominance with Soliris. By leveraging Teva’s commercialization expertise and Samsung Bioepis’s development capabilities, the collaboration aims to bring a more accessible treatment option to patients suffering from rare diseases. The approval and expansion of EPYLLI’s indications further solidify its potential in the global market for biosimilars.-Fineline Info & Tech
