Dr Reddy’s Laboratories has received marketing authorisation from the European Commission (EC) for AVT03, its biosimilar version of denosumab used for treating osteoporosis and cancer-related bone disorders. The approval covers biosimilar equivalents of both Prolia (denosumab) and Xgeva (denosumab).
Prolia is prescribed to treat osteoporosis in postmenopausal women and men at increased risk of fractures, as well as bone loss associated with hormone-ablation therapy in men with prostate cancer and prolonged systemic glucocorticoid use. Xgeva is used to prevent skeletal complications in adults with advanced cancers involving bone and to treat giant cell tumours of the bone in adults and skeletally mature adolescents.
The EC authorisation is valid across all European Union member states and European Economic Area countries, including Iceland, Liechtenstein, and Norway.
In May 2024, Dr Reddy’s and Alvotech entered into a licensing and supply agreement for AVT03. Under the arrangement, Alvotech will develop and manufacture the biosimilar, while Dr Reddy’s will manage regulatory submissions and commercialisation in major markets such as the US and Europe.
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