Dr Reddy's Labs secures European Commission approval for biosimilar to treat osteoporosis

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-11-24 11:00 GMT   |   Update On 2025-11-24 11:00 GMT
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Hyderabad: Dr Reddy's Laboratories has announced that the European Commission 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.
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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.
The European Commission 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 
European Commission 
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.

Read also: Dr Reddy's Labs: Jayanth Sridhar resigns as Global Head of Biologics

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