Alvotech (ALVO) Thursday said that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT03, a biosimilar candidate to Amgen's Prolia and Xgeva (denosumab).
Prolia is indicated to treat osteoporosis in postmenopausal women and in men at increased risk of fracture. Xgeva is used to prevent bone complications in adults with advanced cancer that has spread to the bone, as well as to treat giant cell tumor of bone in adults and adolescents.
In July this year, Alvotech had announced positive topline results from AVT03-GL-C01 and AVT03-GL-P03 studies of AVT03. In both the studies, the primary goals were met showing clinical similarity of AVT03 to Prolia and Xgeva.
"Across all indications, the European denosumab market is currently valued at approximately $1 billion. Biosimilar competition to Prolia and Xgeva could expand patient access considerably at the same or lower overall costs," the company said in a statement.
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