Alvotech announces approval of AVT 03, a biosimilar to Prolia and Xgeva (denosumab) in the European Economic Area

Alvotech announced that the European Commission (EC) has approved AVT 03 as a biosimilar to Prolia and Xgeva (denosumab). AV T03 is approved in two presentations: as a biosimilar to Prolia 60 mg/mL single use pre-filled syringe for the treatment of osteoporosis and bone loss; and as a biosimilar to Xgeva 70 mg/mL single use vial for the prevention of skeletal related events in adults with advanced malignancies involving bone.

The European Commission’s approval of AV T03 as a biosimilar to Prolia and Xgeva 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 men (NCT05126784) and the comparative efficacy study AVT03-GL-C01 in post menopausal women with osteoporosis (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 AV T03 with both Prolia and Xgeva.

The biosimilar will be marketed by Alvotech’s commercial partners, Stada Arzneimittel AG  and Dr. Reddy’s- each partner with semi-exclusive commercial rights in Europe, including Switzerland and the UK. Stada will offer the biosimilar under the tradenames: Kefdensis (denosumab) 60 mg/mL solution for injection in a pre-filled syringe and Zvogra (denosumab) 70 mg/mL solution for injection in a vial, referencing Prolia and Xgeva, respectively while the corresponding trade names for Dr. Reddy’s are Acvybra (denosumab) 60 mg/mL solution for injection in a pre-filled syringe and Xbonzy (denosumab) 70 mg/mL solution for injection in a vial, referencing Prolia and Xgeva, respectively.

“We welcome the European Commission’s approval of AVT03, which demonstrates the continued strength of our end-to-end platform and our ability to deliver high quality biosimilars at scale. This milestone reflects not only the dedication and expertise of our teams, but also the strong partnerships we have built to bring affordable medicines to patients across Europe. Working together, we can help broaden access to essential osteoporosis and oncology supportive care treatments and strengthen the resilience of supply in key markets,” said Robert Wessman, Chairman and Chief Executive Officer of Alvotech.

See citations- Tomaszewska-Kiecana, M., Bullo, F., Jaskiewicz, L. et al. . (2025). A randomized, double-blind, single dose, parallel group, 2-arm study assessing the pharmacokinetic similarity, safety, tolerability, and immunogenicity profiles of biosimilar candidate AVT03 (70 mg/mL) in healthy male adults. Expert Opini Investig Drugs, 2025, 34: 539 https://doi.org/10.1080/13543784. 2025.2505469

Lortkipanidze, M., de Villiers, T., Kania, G et al.  (2025). A randomized, double blind, parallel design, repeat dose, 2-arm, multicenter study comparing the efficacy, safety, immunogenicity, and pharmacokinetic profiles of a denosumab biosimilar, AVT03, in postmenopausal women with osteoporosis. Expert Opinion on Biol Ther, 2025, 25: 899 https://doi.org/10.1080/ 14712598. 2025. 2538609