Celltrion debuts denosumab biosimilars in US
The biosimilars are approved for all indications of the original drugs, Prolia and Xgeva, after Celltrion secured full-label FDA approval in March and finalized a patent settlement with the original manufacturer. The products launched at a wholesale acquisition cost about 5 percent lower than the originals and will be distributed directly through Celltrion's US subsidiary.
To support its market entry, Celltrion signed a supply agreement with a major US hospital group, ensuring product availability from the launch date. The company aims to rapidly expand its presence in the US 'open market,' which accounts for 30 percent of the denosumab segment and is less influenced by pharmacy benefit managers.
The bio giant anticipates revenue growth for the release, as the original drugs, Prolia and Xgeva, generated a combined global revenue of approximately 9.2 trillion won in 2024 worldwide.
'Stoboclo-Osenvelt will expand treatment options for US patients while enhancing accessibility,' said Thomas Nusbickel, chief commercial officer of Celltrion USA. 'We're confident in our ability to scale prescriptions and secure share through both open market and PBM channels.'
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