Biotech company Alvotech S.A. (NASDAQ:ALVO) on Monday reported positive top-line results from a pharmacokinetic (PK) study for AVT03, a biosimilar candidate to Prolia and Xgeva, both containing denosumab.

The study, which assessed the pharmacokinetics, safety and tolerability of AVT03 compared to Prolia in healthy adult subjects, met its primary endpoints. A confirmatory efficacy study is currently underway, as well as a PK study comparing AVT03 to Xgeva in healthy adult subjects.

Prolia and Xgeva are indicated for the treatment of bone disease, with reported combined net revenues exceeding USD6bn in the 12 months to 30 September 2023.

AVT03, an investigational product, targets the RANK ligand membrane protein to reduce osteoclast numbers and function, thereby decreasing bone resorption and cancer-induced bone destruction.