Alvotech touts positive results for denosumab biosimilar

Iceland-based developer of biosimilar medicines, Alvotech (Nasdaq: ALVO) has announced positive top-line results from a pharmacokinetic (PK) study for AVT03, a biosimilar candidate to US biotech major Amgen’s (Nasdaq: AMGN) Prolia and Xgeva, which both having the active ingredient denosumab at different dosages.

The PK study (AVT03-GL-P01), which assessed the pharmacokinetics, safety, and tolerability of AVT03 compared to Prolia in healthy adult subjects, met its primary endpoints. A confirmatory efficacy study for AVT03 in patients is currently underway, as well as a PK study comparing AVT03 to Xgeva in healthy adult subjects.

Alvotech noted that Amgen’s Prolia osteoporosis brand and Xgeva treatment for prevention of skeletal-related events and giant cell tumor together accounted for more than $6 billion in annual sales, for the nine months to September 30, 2023.