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Biosimilars Month in Review: May 2024

FDA Approves High-Concentrate, Citrate-Free Formulation of Biosimilar Adalimumab-adbm

The current approval is based on the VOLTAIRE-HCLF clinical trial, which examined the bioavailability of high-concentration (100 mg/mL) and low-concentration (50 mg/mL) formulations of adalimumab-adbm.

Biosimilar Cyltezo Now Available in High-Concentration Formulation

The high-concentration formultion (100mg/mL) is available as a prefilled syringe (40mg/0.4mL) or prefilled autoinjector.

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