在美国食品药品监督管理局批准首款地舒单抗（denosumab）生物仿制药近一年后，该机构与欧洲药品管理局（EMA）一起宣布批准了另外两种生物仿制药（denosumab-dssb；SB16），其中引用了Prolia/Xgeva（denosuma）。

The FDA has approved two new denosumab biosimilars that are interchangeable with the reference medications Prolia and Xgeva, ...

Denosumab-bnht is expected to launch in the US in June 2025 per an agreement with the reference product’s manufacturer, Amgen ...

The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, ...

The study explores whether denosumab, a widely used therapy for osteoporosis and bone tumors, can regenerate beta cells, ...

On March 5, 2025, the FDA cleared an investigational new drug application for CTD402, a CD7-targeted universal CAR T-cell ...

The study included 2 treatment periods. During the first period, study participants (N=479) were randomly assigned 1:1 to receive denosumab-bmwo or the reference product. Patients who received the ...

Longer durations of denosumab treatment improved the probability of achieving target T-scores at the total hip and lumbar spine in postmenopausal women with osteoporosis. Denosumab treatment ...

Osvyrti ®– Bone / Osteoporosis (60mg Pre-Filled Syringe) Jubereq ®– Oncology (120mg Vial) Joe Dunford, Accord's Vice ...

The FDA approved denosumab-bmwo for all indications of the reference drugs Prolia and Xgeva. According to a settlement between Amgen and Celltrion, the biosimilars can be launched as early as June 1.

Longer durations of denosumab treatment improved the probability of achieving target T-scores at the total hip and lumbar spine in postmenopausal women with osteoporosis. Denosumab treatment ...

On March 26, 2025, the FDA approved Fresenius Kabi’s denosumab biosimilars, CONEXXENCE® (denosumab-bnht) and BOMYNTRA® (denosumab-bnht), ...