In an official statement dated November 24, the company said the authorization covers all EU Member States as well as countries within the European Economic Area, including Iceland, Liechtenstein and Norway. AVT03 (denosumab) is indicated for conditions such as osteoporosis in postmenopausal women and bone-related complications arising from advanced cancers, based on the referenced products Prolia and Xgeva.
The approval follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) in September 2025.
According to the company, the decision was supported by analytical comparisons, pharmacokinetic and pharmacodynamic assessments, and outcomes from a confirmatory clinical trial.
Dr. Reddy’s entered into a licensing and supply agreement with Alvotech in May 2024 for AVT03. Under this arrangement, Alvotech will manufacture the product, while Dr. Reddy’s will handle registration and commercialization across key markets, including the U.S. and Europe.
Commercialization rights will be exclusive to Dr. Reddy’s in the U.S. and semi-exclusive in Europe and the UK. Following approval, the biosimilar will be marketed under the brands Acyvbra for a 60 mg/mL pre-filled syringe formulation and Xbonzy for a 70 mg/mL vial injection.AVT03 is a human monoclonal IgG2 antibody and biosimilar candidate to Prolia and Xgeva, which are both denosumab but in different presentations. Denosumab targets and binds with high affinity and specificity to the RANK ligand membrane protein, preventing the RANK ligand/RANK interaction from occurring, resulting in reduced osteoclast numbers and function, thereby decreasing bone resorption and cancer-induced bone destruction.Also read: Ashish Kacholia, Anil Goel, Mukul Agrawal & Ashish Dhawan lose big as portfolios crash up to 29%
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