Alvotech announces positive findings from study of denosumab biosimilar

Alvotech has reported positive topline data from the AVT03-GL-C01 study, evaluating AVT03 as a biosimilar to denosumab drugs Prolia and Xgeva. This randomized, double-blind study included 532 postmenopausal women with osteoporosis, assessing efficacy, safety, immunogenicity, and pharmacokinetics. Participants were randomized to receive three doses of AVT03 or Prolia at six-month intervals, with re-randomization for the third Prolia dose.

Primary outcomes measured changes in bone mass density (BMD) and bone resorption biomarkers to demonstrate AVT03's clinical similarity to Prolia, successfully meeting study endpoints.

Additionally, Alvotech conducted AVT03-GL-P01 and AVT03-GL-P03 studies, comparing AVT03's pharmacokinetics, safety, and tolerability to Prolia and Xgeva in over 200 healthy adults each, achieving primary objectives.

These results support AVT03's potential as a biosimilar for Xgeva, expanding treatment options for conditions like osteoporosis and advanced malignancies involving bone.