European Commission Clears Dr. Reddy’s AVT03 Biosimilar for Launch Across EU and EEA

26 Nov 2025 , 10:21 AM

Dr. Reddy’s Laboratories announced that the European Commission has approved marketing authorization for AVT03, its biosimilar version of Prolia and Xgeva. The authorization covers all European Union member states and the European Economic Area nations Iceland, Liechtenstein and Norway.

AVT03 has been developed as a biosimilar to denosumab, the active ingredient used in Prolia and Xgeva. Prolia is prescribed to treat osteoporosis in postmenopausal women and in men who face a higher risk of fractures. It is also used to manage bone loss associated with long-term glucocorticoid use and hormone ablation therapy in prostate cancer patients.

Xgeva is used in adults with advanced cancers that have spread to bone. It also supports adults and skeletally mature adolescents diagnosed with giant cell tumour of bone by helping prevent serious bone-related complications.

The European Commission’s decision follows the positive scientific opinion issued by the Committee for Medicinal Products for Human Use in September 2025. The approval is based on analytical comparisons, pharmacokinetic and pharmacodynamic studies and results from a confirmatory clinical trial that established similarity with the reference products.

Dr. Reddy’s and Alvotech have been working together on AVT03 under a license and supply agreement signed in May 2024. Alvotech is responsible for developing and manufacturing the biosimilar, while Dr. Reddy’s will handle regulatory filings and market launch across regions including Europe and the United States.

As part of the agreement, Dr. Reddy’s holds exclusive commercialization rights in the United States and semi exclusive rights in Europe and the United Kingdom.

Once launched, AVT03 will be available under two tradenames. Acvybra will be marketed as a 60 mg per millilitre solution in a pre filled syringe. Xbonzy will be offered as a 70 mg per millilitre solution in a vial.

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