Alvotech announced that the European Commission (EC) has approved AVT03 as a biosimilar to Prolia and Xgeva®? (denosumab). The European denosumab market is currently valued at approximately USD 1.2 billion across all indications, based on originator sales in the last 12 months including the second quarter of 2025.
Denosumab is widely used to manage osteoporosis and to prevent skeletal related events in patients with certain cancers. A biosimilar option can help broaden access to these established treatments in Europe. Dr. Reddy's will market AVT03 as Acvybra®?, biosimilar to Prolia®?
and as Xbonzy®?, biosimilar to Xgeva®?. The European Commission's approval of AVT03 as a bios dissimilar to Prolia and X geva was based on a totality of evidence that included comparative analytical, pharmacokinetic and pharmacodynamic data, and data from a confirmatory clinical study. The clinical data package included the PK similarity study AVT03-GL-P01 in healthy adult males (ClinicalTrials.gov identifier NCT05126784) and the comparative efficacy study AVT03-GL -C01 in post menopausal women with osteoporosis (ClinicalTrials.com identifier NCT05395091) with Prolia used as the reference product in both clinical studies.
The results of the clinical studies demonstrate equivalent pharmacokinetics and efficacy, and comparable safety and immunogenicity to the reference product and were reported in peer reviewed publications. Analytical similarity studies also compared AVT03 with both Prolia and Xgeva.
