TEVA(TEVA) Newsfilter·2025-01-10 13:30Partnership Agreement - Samsung Bioepis and Teva Pharmaceutical Industries have entered into a license, development, and commercialization agreement for EPYSQLI®, a biosimilar to Soliris®, in the US [1] - Samsung Bioepis will handle development, regulatory registration, manufacturing, and supply, while Teva will manage commercialization in the US [2] - EPYSQLI is indicated for treating rare diseases including paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and generalized myasthenia gravis (gMG) [3] Strategic Importance - The partnership aims to increase access to treatment for rare disease patients, addressing high costs and limited availability [4] - The collaboration aligns with Teva's Pivot to Growth strategy, expanding its biosimilar portfolio to 18 assets [5] - Samsung Bioepis' biosimilars portfolio now includes nine biosimilars available in over 40 countries, covering therapeutic areas such as immunology, oncology, and hematology [5] Regulatory Approvals - EPYSQLI was approved by the US FDA in July 2024 for PNH and aHUS, with an expanded indication for gMG in November 2024 [4] - The product received approval from the European Commission in May 2023 and Korea's Ministry of Food and Drug Safety in January 2024 [4] - EPYSQLI has been commercially available in Europe since July 2023 and in Korea since April 2024 [4] Product Details - EPYSQLI is a complement inhibitor used to treat PNH, aHUS, and gMG in adult patients who are anti-acetylcholine receptor (AchR) antibody positive [3][6] - The product is not indicated for Shiga toxin E coli-related hemolytic uremic syndrome (STEC-HUS) [8] - EPYSQLI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) due to the risk of serious meningococcal infections [10][17] Safety Information - EPYSQLI increases the risk of serious infections caused by Neisseria meningitidis, which can be life-threatening or fatal [9][12] - Patients must complete or update meningococcal vaccination at least two weeks prior to the first dose of EPYSQLI [13][15] - Monitoring for early signs of meningococcal infection is critical, and treatment should be interrupted if serious infection occurs [16] Adverse Reactions - Common adverse reactions in PNH trials include headache, nasopharyngitis, back pain, and nausea [27] - In aHUS trials, frequent adverse reactions include headache, diarrhea, hypertension, and upper respiratory infection [27] - In gMG trials, musculoskeletal pain was the most frequently reported adverse reaction [28]