FDA approves second adalimumab biosimilar for multiple conditions


The Food and Drug Administration has approved Cyltezo (adalimumab-adbm) for multiple conditions.

Cyltezo is an injectable tumor necrosis factor blocker, and is a biosimilar to adalimumab (Humira). The drug is indicated to treat moderate to severe active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, moderate to severe active Crohn’s disease, moderate to severe active ulcerative colitis, moderately to severely active polyarticular juvenile idiopathic arthritis in patients 4 years of age and older, and moderate to severe plaque psoriasis.

The most common side effects are injection site infections, infection, rash, and headache. There is an increased risk of serious infection and malignancies such as lymphoma, and patients with active infections should not be started on Cyltezo.

Find the Cyltezo labeling information here.

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