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FDA Approves Cyltezo, an Interchangeable Biosimilar to Humira

U.S. Food & Drug Administration  |  October 19, 2021

Cyltezo, offered in a single-dose, pre-filled glass syringe (40 mg/0.8 mL, 20 mg/0.4 mL), is administered subcutaneously under the guidance of a physician. The most serious known side effects with Cyltezo are infections and malignancies (cancers). The most common expected adverse reactions are upper respiratory and sinus infections, injection site reactions, headache and rash.

Like Humira, the labeling for Cyltezo contains a Boxed Warning to alert healthcare professionals and patients to an increased risk of serious infections that may lead to hospitalization or death. The Boxed Warning also notes that lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor blockers, including adalimumab products. The drug must be dispensed with a patient Medication Guide that describes important information about its uses and risks.

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Filed under:Biologics/DMARDsDrug Updates Tagged with:adalimumabadalimumab-adbmBiosimilarsCyltezoFDA approvalHumiraU.S. Food and Drug Administration (FDA)

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