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EC nod for Dr Reddy’s bone medicine

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Dr Reddys posts 1 pc drop in net profit at Rs 1,392 crore in Q1, revenue up 14 pc
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25 Nov 2025 10:25 AM IST

New Delhi: Dr Reddy’s Laboratories on Monday said the European Commission (EC) 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. 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.

Dr Reddy’s Laboratories European Commission marketing authorisation biosimilar approval AVT03 Prolia biosimilar Xgeva biosimilar denosumab osteoporosis treatment postmenopausal osteoporosis fracture risk hormone ablation therapy prostate cancer bone loss glucocorticoid-induced bone loss bone complications giant cell tumour of bone oncology pharmaceutical approval Hyderabad drug firm EU regulatory approval biosimilar drugs. 
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