Dr Reddy’s Receives European Commission Approval for AVT03 Biosimilar Denosumab

On November 24, 2025, Dr Reddy’s Laboratories announced that the European Commission (EC) has granted marketing authorisation for AVT03, its proposed biosimilar referencing Prolia and Xgeva. This approval strengthens the company’s expanding global biosimilars portfolio. 

EC Approval Enables Market Expansion Across Europe 

The EC decision follows a positive opinion from the Committee for Medicinal Products for Human Use in September 2025. Approval covers all EU Member States and the EEA, including Iceland, Liechtenstein and Norway.  

AVT03 is a biosimilar to denosumab, used in the treatment of osteoporosis, fracture risk reduction and prevention of bone complications in cancer. The approval was supported by analytical comparisons, pharmacokinetic and pharmacodynamic evaluations and data from a confirmatory clinical study. 

Collaboration with Alvotech for Development and Supply 

Under a licence and supply agreement signed in May 2024, Alvotech will develop and manufacture AVT03, while Dr Reddy’s will handle registration and commercialisation in key markets such as the US and Europe.  

Commercial rights are exclusive in the US and semi-exclusive in Europe and the UK. Upon launch, Dr Reddy’s will market AVT03 under the tradenames Acvybra, a 60 mg/mL prefilled syringe, and Xbonzy, a 70 mg/mL vial. 

About AVT03 and Its Therapeutic Role 

AVT03 is a human monoclonal IgG2 antibody that targets the RANK ligand protein. By blocking RANK ligand and RANK interaction, it reduces osteoclast activity, helping manage bone resorption and cancer induced bone damage. As a biosimilar to well established denosumab products, AVT03 aims to increase accessibility in major therapeutic categories. 

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Dr Reddy's Laboratories Share Price Performance  

As of November 24, 2025, at 3:30 PM, Dr Reddy's Laboratories share price closed at ₹1,226.20 down by 1.42% from the previous closing price. 

Conclusion 

The EC approval of AVT03 marks an important milestone for Dr Reddy’s as it advances its biosimilars strategy across global markets. The decision enhances the company’s position in Europe and supports broader growth plans in oncology and immunology. 

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