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 ...
On March 26, 2025, the FDA approved Fresenius Kabi’s denosumab biosimilars, CONEXXENCE® (denosumab-bnht) and BOMYNTRA® (denosumab-bnht), ...
The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, ...
The approval was based on a comprehensive clinical data package, which included a single phase 1 trial and a phase 3 trial.
City of Hope, one of the largest and most advanced cancer research and treatment organizations in the United States and a top ...
Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence® (denosumab-bnht) and Bomyntra® (denosumab-bnht) of its operating company Fresenius Kabi, has ...
The FDA approved another set of denosumab biosimilars, Conexxence/Bomyntra (denosumab-bnht), expanding treatment options for ...
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 ...
Researchers predicted the likelihood of achieving target T-scores in postmenopausal women with osteoporosis who received denosumab therapy for 10 years.
Dr. Reddy’s Laboratories RDY and partner, Alvotech ALVO, announced the FDA’s acceptance of a regulatory filing, seeking the ...
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