Alvotech declares positive findings from study of denosumab biosimilar

Alvotech has announced positive top-line results from its confirmatory patient study, AVT03-GL-C01, evaluating AVT03 as a proposed biosimilar to denosumab drugs Prolia and Xgeva. This randomized, multi-center, double-blind study compared AVT03 and Prolia in postmenopausal women with osteoporosis, enrolling nearly 532 participants aged 50 and above. Participants received three doses of either AVT03 or Prolia at six-month intervals, with a re-randomization for the third dose in the Prolia group.

Primary outcome measures included changes in bone mass density (BMD) and a bone resorption biomarker. The study aspired to demonstrate AVT03's clinical similarity to Prolia in terms of efficacy, safety, immunogenicity, and pharmacokinetics.

Alvotech also conducted two additional studies, AVT03-GL-P01 and AVT03-GL-P03, assessing AVT03 against Prolia and Xgeva, respectively, in over 200 healthy adult participants each. Both studies favourably met their primary endpoints.

These findings aim to support AVT03's use as a biosimilar for various indications, including Xgeva.

Prolia is presently prescribed for osteoporosis in postmenopausal women and bone loss in adults at higher fracture risk.