European Medicines Agency Confirms Acceptance of Marketing Application for AVT03, a Proposed Biosimilar to Prolia® and Xgeva®

Core Insights - Alvotech has received acceptance from the European Medicines Agency (EMA) for the Marketing Authorization Application of AVT03, a biosimilar candidate to Prolia® and Xgeva® (denosumab), marking a significant step towards patient access in Europe [1][2] - The company aims to leverage its end-to-end biosimilars platform to enhance access to affordable biologic medicines [1] - Alvotech has partnered with STADA Arzneimittel AG and Dr. Reddy's Laboratories SA for the commercialization of AVT03 in Europe, with each partner holding semi-exclusive rights [1] Company Overview - Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines [7] - The company has already approved and marketed two biosimilars, targeting autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer [8] - Alvotech has established a network of strategic commercial partnerships across various global markets, including the US, Europe, and Asia [8] Product Details - AVT03 is a human monoclonal antibody that targets the RANK ligand, reducing bone resorption and cancer-induced bone destruction [5] - The European market for denosumab is valued at approximately US$1 billion, indicating significant potential for biosimilar competition to enhance patient access [3][4] - In 2019, the direct cost of osteoporotic fractures in the EU, Switzerland, and the UK was estimated at US$63 billion, highlighting the economic burden of osteoporosis [4] Clinical Study Results - Alvotech announced positive topline results from a confirmatory patient study for AVT03, demonstrating clinical similarity to Prolia in terms of efficacy, safety, immunogenicity, and pharmacokinetics in postmenopausal women with osteoporosis [2] - The AVT03-GL-C01 study met its primary endpoints, as did two additional studies comparing AVT03 to Prolia and Xgeva in healthy adult participants [2]