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.

Taken alongside Prolia/Xgeva, the brands account for well over 40% of Amgen's current revenues. Other companies working on biosimilar versions of denosumab include Samsung Bioepis, Celltrion, and ...

Alvotech and Dr. Reddy’s Announce FDA acceptance of Biologic License Application for AVT03, a Proposed Biosimilar to Prolia® and Xgeva® Alvotech Tue, Mar 18, 2025, 8:30 AM 11 min read ...

AMGN’s Xgeva helps prevent fractures, spinal cord compression and the need for bone-related surgery or radiation in patients with multiple myeloma or bone metastases from solid tumors.

The Food and Drug Administration has approved Fresenius Kabi's Biologics License Application for the denosumab biosimilars Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht). These ...

Celltrion has received permission from the Food and Drug Administration for Stoboclo (CT-P41, denosumab-bmwo) and Osenvelt (CT-P41, denosumab-bmwo), biosimilars referencing Prolia (denosumab ...