European Medicines Agency Recommends Marketing Authorization of AVT03, Alvotech’s Proposed Biosimilar to Prolia® and Xgeva®

Core Viewpoint - Alvotech has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use recommending approval for its biosimilar AVT03, which is a proposed alternative to Prolia and Xgeva, pending final decision by the European Commission [1][4]. Company Overview - Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines, aiming to provide affordable biologic treatments to patients worldwide [7]. - The company has already approved and marketed two biosimilars, targeting Humira and Stelara, and has a pipeline of nine additional biosimilar candidates for various conditions [7]. Product Details - AVT03 is a human monoclonal antibody biosimilar candidate to Prolia (denosumab 60 mg/mL) and Xgeva (denosumab 70 mg/mL) [5]. - Prolia is used for treating osteoporosis and bone loss in specific patient populations, while Xgeva is indicated for preventing bone complications in advanced cancer patients [3]. Commercial Partnerships - Upon approval, Alvotech's commercial partners, STADA and Dr. Reddy's, will market AVT03 in Europe, with STADA using the tradenames Kefdensis and Zvogra, and Dr. Reddy's using Acvybra and Xbonzy [4][6].