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Dr. Reddy's receives European Commission Approval for AVT03 (denosumab), a Proposed Biosimilar of Prolia® and Xgeva®
Posted On : 2025-11-24 17:07:35( TIMEZONE : IST )
Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; along with its subsidiaries together referred to as "Dr. Reddy's"), today announced that the European Commission (EC) has granted marketing authorization for AVT03, a biosimilar of Prolia® (denosumab) and Xgeva® (denosumab).
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 [1]. 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 [2].
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.
In May 2024, Dr. Reddy's and Alvotech entered into a license and supply agreement for the commercialization of AVT03. Under the agreement, Alvotech will develop and manufacture AVT03, while Dr. Reddy's is responsible for registration and commercialization in applicable markets, including the U.S. and Europe. Dr. Reddy's commercialization rights are exclusive for the U.S., and semi-exclusive for Europe and the UK. 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.
