FDA Approves Cyltezo, the Second Humira Biosimilar

On August 25, 2017, the FDA approved Cyltezo (adalimumab-adbm), the second Humira biosimilar.1 Cyltezo, like Humira, is a tumor necrosis factor (TNF) blocker indicated for treating adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, moderately to severely active Crohn’s disease, moderately to severely active ulcerative colitis, and moderate-to-severe plaque psoriasis.1,2 Additionally, Cyltezo is approved for children aged 4 years or older with moderately to severely active polyarticular juvenile idiopathic arthritis.

Cyltezo is administered by subcutaneous injection (40 mg/0.8 mL).1,2

Similar to Humira, serious side effects for patients taking Cyltezo include infection and malignancies.1,2 The prescribing information for Cyltezo includes a boxed warning regarding an increased risk of serious infections leading to hospitalization or death, including tuberculosis, bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. It also includes a warning that lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. Cases of hepatosplenic T-cell lymphoma have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers, including adalimumab products.

For the full prescribing information for Cyltezo, click here.

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