Dr. Reddy’s Laboratories Ltd. announced that the European Commission (EC) has granted marketing authorization for AVT03, a biosimilar to Prolia® and Xgeva® (denosumab). The authorization covers all European Union member states and the European Economic Area (EEA) countries, including Iceland, Liechtenstein, and Norway.
AVT03 will be marketed under the brand names 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).
Prolia® is widely used for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures, as well as for managing bone loss associated with hormone ablation therapy or long-term glucocorticoid use. Xgeva® is indicated for preventing skeletal-related events in adults with advanced cancers involving bone and for treating giant cell tumour of bone in adults and skeletally mature adolescents.
The EC decision follows a positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) in September 2025. The authorization is based on a comprehensive evidence package, including analytical data, pharmacokinetic and pharmacodynamic studies, and results from a confirmatory clinical trial demonstrating biosimilarity to the reference products.
In May 2024, Dr. Reddy’s entered into a license and supply agreement with Alvotech for the commercialization of AVT03. Under this collaboration, Alvotech is responsible for developing and manufacturing the product, while Dr. Reddy’s will oversee regulatory submissions and commercialization in key markets, including Europe and the United States. Dr. Reddy’s holds exclusive commercialization rights for the U.S. and semi-exclusive rights for Europe and the UK.