FDA Approves Biosimilar to Humira

The FDA has approved adalimumab-adbm (Cyltezo), a biosimilar of Humira (adalimumab), for the treatment of multiple inflammatory diseases.

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

Cyltezo is a tumor necrosis factor blocker approved for the treatment of adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, moderately to severely active Crohn disease, moderately to severely active ulcerative colitis, and moderate-to-severe plaque psoriasis.

It is also approved for children aged 4 years or older with moderate to severe active polyarticular juvenile idiopathic arthritis.

Infections and malignancies are the most common adverse events associated with adalimumab-adbm. As with adalimumab, adalimumab-adbm has a boxed warning of increased risk of serious and sometimes fatal infections. Lymphoma and other malignancies have also occurred in children and adolescents treated with TNF inhibitors.

—Michael Potts