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Positive Topline Results for Alvotech’s Denosumab Biosimilar

Jul 2, 2024

Alvotech announced positive topline results from a confirmatory clinical study for AVT03 (denosumab), biosimilar to Amgen’s Prolia® and Xgeva®. The study, involving 532 postmenopausal women with osteoporosis, met its primary endpoints, demonstrating clinical similarity in efficacy, safety, immunogenicity, and pharmacokinetics (PK) between AVT03 and Prolia®. Positive results from two additional PK studies comparing AVT03 with Prolia® and Xgeva® also showed equivalent safety and tolerability.  

Alvotech’s announcement states that it expects to file marketing applications for AVT03 in major global markets later in 2024. 

This comes after Alvotech’s announcement last month that it has expanded its current partnership with STADA to include AVT03 for EU, UK and Switzerland. 

Denosumab biosimilars have been approved in the US and EU (Sandoz’s Jubbonti® and Wyost®) and in China (Boan Biotech’s Byoubei® and Boluojia® and Mabwell’s Mailishu® and MaiweijianTM).