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Dr. Reddy's Secures European Commission Nod For Prolia/Xgeva Biosimilar

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us

Dr. Reddy's Laboratories Ltd. (RDY) said Monday that the European Commission has granted marketing authorization for AVT03, a biosimilar to Amgen's Prolia and Xgeva.

Prolia is prescribed for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures, as well as for bone loss associated with hormone ablation in men with prostate cancer and with long-term systemic glucocorticoid therapy. Xgeva is used to prevent bone complications in adults with advanced cancers involving bone and to treat adults and skeletally mature adolescents with giant cell tumour of bone.

Under a 2024 license and supply agreement, Alvotech will develop and manufacture AVT03, while Dr. Reddy's will handle registration and commercialization in key markets, including the U.S. and Europe. Dr. Reddy's plans to market the product under the tradenames Acvybra (pre-filled syringe) and Xbonzy (vial).

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