Drug Topics May 3, 2024
Check out important updates from the FDA for the week of April 29.
FDA Approves Second Formulation of Humira Biosimilar Cyltezo
The FDA approved Boehringer Ingelheim’s adalimumab-abdm (Cyltezo), a high-concentration, citrate-free, interchangeable Humira (adalimumab; AbbVie) biosimilar to treat several chronic inflammatory diseases.
Adalimumab-abdm is indicated to reduce the signs and symptoms of moderate-to-severe rheumatoid arthritis in adults; moderate-to-severe polyarticular juvenile idiopathic arthritis in children 2 years and older; psoriatic arthritis in adults; ankylosing spondylitis in adults; and moderate-to-severe hidradenitis suppurativa in adults. It is further indicated to treat moderate-to-severe Crohn’s disease in adults and children 6 years of age and older; moderate-to-severe ulcerative colitis in adults; moderate-to-severe chronic plaque psoriasis in adults; and non-infectious intermediate, posterior, and panuveitis in adults.
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