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News about "Prolia"
Dr. Reddy's Receives Positive CHMP Opinion from European Medicines Agency for Denosumab
Dr. Reddy’s Laboratories has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for AVT03, a proposed biosimilar to Prolia and Xgeva, moving it closer to potential marketing authorisation in the European Economic Area (EEA).
Prolia | 24/09/2025 | By Dineshwori
Aurobindo's Subsidiary CuraTeQ Biologics Completes Phase 3 Clinical Study for Denosumab Biosimilar
CuraTeQ Biologics, a wholly owned subsidiary of Aurobindo Pharma, has successfully completed a pivotal clinical study of its denosumab biosimilar, evaluated against Amgen’s Prolia in 446 women with postmenopausal osteoporosis.
Prolia | 19/09/2025 | By Dineshwori | 191
Biocon Biologics Secures US FDA Approval for Denosumab Biosimilars Bosaya and Aukelso
The US Food and Drug Administration (FDA) has approved Biocon Biologics' denosumab biosimilars, Bosaya (denosumab-kyqq) 60 mg/mL injection in a single-dose prefilled syringe (PFS) and Aukelso (denosumab-kyqq) 120 mg/1.7 mL (70 mg/mL) injection in a single-dose vial, biosimilars of Prolia and Xgeva, respectively.
Prolia | 17/09/2025 | By Dineshwori | 347
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