Alvotech Announces Approval of AVT03, a Biosimilar to Prolia® and Xgeva® (denosumab) in the European Economic Area

Core Viewpoint - Alvotech has received approval from the European Commission for AVT03 as a biosimilar to Prolia and Xgeva, which is expected to enhance access to treatments for osteoporosis and cancer-related skeletal issues in Europe [1][4][5]. Company Summary - Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines, aiming to be a leader in the biosimilar space by providing high-quality, cost-effective products [11]. - The approval of AVT03 reflects Alvotech's strong end-to-end platform and its commitment to delivering affordable medicines to patients [4][5]. - Alvotech has established strategic partnerships for the commercialization of AVT03 in Europe, collaborating with STADA and Dr. Reddy's, each holding semi-exclusive rights in various regions [7][12]. Product Summary - AVT03 is approved in two forms: as a 60 mg/mL single-use pre-filled syringe for osteoporosis treatment and as a 70 mg/mL single-use vial for preventing skeletal-related events in cancer patients [3][9]. - The European denosumab market is valued at approximately US$1.2 billion, indicating a significant opportunity for AVT03 to capture market share [2]. - The approval was based on comprehensive evidence, including pharmacokinetic and pharmacodynamic data, and clinical studies demonstrating equivalent efficacy and safety compared to the reference products [8]. Market Context - Osteoporosis-related disabilities in Europe surpass those caused by common cancers, highlighting the importance of effective treatments [6]. - The economic burden of fragility fractures in Europe was estimated at €57 billion in 2019, underscoring the need for cost-effective treatment options like biosimilars [6][7].