On November 24, 2025, Alvotech announced that the European Commission (EC) has approved AVT03 as a biosimilar to Amgen’s PROLIA® and XGEVA® (denosumab) in the European Economic Area. AVT03 is approved ...
Shanghai Henlius Biotech and Organon have received permission from the Food and Drug Administration for Bildyos (denosumab-nxxp) injection 60 mg/ml and Bilprevda (denosumab-nxxp) injection 120 mg/1.7 ...
Sandoz has launched Wyost® (denosumab 120 mg) and Jubbonti® (denosumab 60 mg) across Europe, among the first denosumab biosimilars approved for all Xgeva® and Prolia® indications, targeting ...
Basel, March 5, 2024 – Sandoz, the global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) approved Wyost® (denosumab-bbdz) and Jubbonti® ...
∇ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. LONDON, Dec. 2, 2025 /PRNewswire/ -- Accord Healthcare today announced the launch ...
Biosimilar competition to Amgen Inc.’s denosumab (Prolia/Xgeva) is rising globally, with Mabwell (Shanghai) Bioscience Co. Ltd. gaining the latest China NMPA approval of Maiweijian (TK-006) on April 8 ...
Changes in Invasive Breast Cancer and Ductal Carcinoma In Situ Rates in Relation to the Decline in Hormone Therapy Use Patients were randomly assigned to receive either subcutaneous denosumab 120 mg ...
Samsung Bioepis Co., Ltd. has secured marketing approval in Korea for XBRYK, its biosimilar to Amgen’s bone cancer drug XGEVA, used to prevent fractures in those with bone metastases from solid tumors ...
Amgen announced that a phase 3 study evaluating Xgeva (denosumab) versus zoledronic acid met the primary endpoint of non-inferiority (hazard ratio = 0.98, 95 per cent CI, 0.85 - 1.14) in delaying the ...
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