FDA approves high-concentration, citrate-free Cyltezo biosimilar for multiple chronic inflammatory diseases, interchangeable with Humira.
The FDA has approved a high-concentration, citrate-free form of the interchangeable adalimumab biosimilar Cyltezo for treating multiple chronic inflammatory diseases. The approval was supported by extensive data, including findings from the VOLTAIRE-HCLF trial. Cyltezo is an interchangeable biosimilar to Humira and can be substituted for the reference product without a prescription change. The high-concentration formulation is available as a prefilled syringe or prefilled autoinjector.
May 01, 2024
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