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Celltrion Regulatory Requirements

Goodwin

FDA Grants Interchangeability Designation to Fresenius Kabi’s and Celltrion’s Denosumab Biosimilars

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This week the FDA granted interchangeability status to Fresenius Kabi’s and Celltrion’s respective denosumab biosimilars.  Interchangeable biosimilars can be substituted for the reference product at the pharmacy without...more

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FDA Approves Expanded Indication for Celltrion’s AVTOZMA for the Treatment of Cytokine Release Syndrome

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On August 7, 2025, Celltrion announced that it obtained FDA approval expanding the indication of the intravenous (IV) formulation of AVTOZMA (tocilizumab-anoh) to include treatment of cytokine release syndrome (CRS) in...more

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