Hyderadbad-based Dr Reddy’s gets European approval for osteoporosis biosimilar AVT03

Dr Reddy’s Laboratories has secured European Commission approval for AVT03, its biosimilar of Prolia and Xgeva used in treating osteoporosis and bone-related conditions. Developed by Alvotech, the product will be commercialised by Dr Reddy’s across the US, Europe, and other market

New Delhi: Dr Reddy’s Laboratories on Monday said the European Commission has granted marketing authorisation for its biosimilar to treat osteoporosis. The company has received approval for AVT03, a biosimilar of Prolia (denosumab) and Xgeva (denosumab), the Hyderabad-based drug firm said in a statement.

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 glucocorticoids.

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Xgeva is also 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 tumours of bone.

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 commercialisation of AVT03.

Under the agreement, Alvotech will develop and manufacture AVT03, while Dr Reddy’s is responsible for registration and commercialisation in applicable markets, including the US and Europe.

Dr Reddy’s shares on Monday ended 1.59 per cent down at Rs 1,224.75 apiece on BSE.