Biosimilar FDA-Approved for Myeloma Bone Strengthener Denosumab

On February 13, 2025, the U.S. Food and Drug Administration (FDA) approved a biosimilar of the bone strengthener denosumab for people with multiple myeloma. 

Denosumab was FDA-approved for myeloma under the brand name Xgeva (Amgen) in 2018. The newly approved biosimilar, Xbryk (Samsung Bioepis), provides the same safety and effectiveness at a lower cost, making treatment more accessible. 

How Does Denosumab Work for People with Myeloma? 

Denosumab is an injectable monoclonal antibody that supports patients by blocking a protein called RANKL. This stops bone-destroying cells from breaking down bones too quickly, helping strengthen bones, reduce fractures, and relieve bone pain caused by myeloma. 

Unlike other bone strengtheners such as bisphosphonates, denosumab is not cleared through the kidneys, thereby protecting kidney health. Supporting myeloma patients’ kidney function is important as they can develop kidney issues during the cancer course. 

Watch the HealthTree University video below to learn when your myeloma specialist may recommend denosumab. 

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Sources: 

• FDA-Approved XBRYK
• FDA Approves Samsung Bioepis’ OSPOMYV™, XBRYK™ (denosumab-dssb), a Biosimilar to Prolia and Xgeva
• All About Denosumab