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Alvotech commences confirmatory study for denosumab biosimilar

Aug 25, 2022

Alvotech announced that it has commenced a confirmatory patient study for AVT03 (biosimilar to Prolia® and Xgeva®, denosumab).  The objective of the study is to demonstrate clinical similarity of AVT03 to Prolia® in terms of efficacy, safety, immunogenicity and pharmacokinetics in postmenopausal women with osteoporosis.  The results from this trial will be used to extrapolate to additional Xgeva® indications.  Alvotech commenced phase I trials for denosumab in July 2022.

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