Mabwell Strengthens China Pipeline with NMPA Acceptance for Denosumab
Mabwell announces NMPA acceptance of its sBLA for MAIWEIJIAN (denosumab), China’s first approved 120mg denosumab biosimilar, used to treat giant cell tumor of bone in adults and adolescents.
Denosumab Biosimilar | 17/04/2026 | By News Bureau
Dr. Reddy's Wins European Approval for Denosumab Biosimilar
Dr. Reddy’s Laboratories has received approval from the European Commission for its denosumab biosimilar, used in the treatment of osteoporosis and cancer-related bone conditions.
Denosumab Biosimilar | 25/11/2025 | By Darshana | 203
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).
Denosumab Biosimilar | 24/09/2025 | By Dineshwori | 183
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.
Denosumab Biosimilar | 19/09/2025 | By Dineshwori | 396
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