By: IPP Bureau
Last updated : November 24, 2025 5:21 pm
AVT03 is a biosimilar of Amgen's Prolia (denosumab 60 mg/mL) and Xgeva (denosumab 70 mg/mL), which are used to treat various bone conditions
The European Commission has granted marketing authorization for Dr. Reddy's Laboratories' AVT03 (denosumab), a biosimilar referencing Prolia and Xgeva, for use across the European Union and the European Economic Area.
AVT03 is a biosimilar of Amgen's Prolia (denosumab 60 mg/mL) and Xgeva (denosumab 70 mg/mL), which are used to treat various bone conditions.
The EC decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) adopted in September 2025 and was based on a totality of evidence, including analytical comparisons, pharmacokinetic and pharmacodynamic data, and outcomes from a confirmatory clinical trial. The EC decision is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway.
Prolia is a prescription medicine used to treat osteoporosis in women who have been through menopause and in men who are at increased risk of fractures, bone loss linked to hormone ablation in men with prostate cancer at increased risk of fractures and bone loss associated with long-term treatment with systemic glucocorticoid.
Xgeva is a prescription medicine used to prevent bone complications in adults with advanced cancer involving bone and for the treatment of adults and skeletally mature adolescents with giant cell tumour of bone.
Dr. Reddy's holds the commercialization rights for AVT03 in key markets, including the U.S. and Europe, under a license and supply agreement with Alvotech, who will develop and manufacture the product.
Upon approval Dr. Reddy’s will offer the biosimilar under the tradenames 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.