The FDA has approved adalimumab-adbm (Cyltezo, Boehringer Ingelheim), a biosimilar of Humira (AbbVie) for multiple indications.

Adalimumab-adbm, which is administered by subcutaneous injection, is the second FDA approval related to Humira. The first, adalimumab-atto (Amjevita, Amgen), was approved almost a year ago.

A tumor necrosis factor (TNF) blocker, adalimumab-adbm was approved for adults with moderately to severely active rheumatoid arthritis; Crohn’s disease and ulcerative colitis; moderate to severe plaque psoriasis; and active psoriatic arthritis and ankylosing spondylitis.

The FDA also granted an indication for use in pediatric patients aged 4 years or older with moderately to severely active polyarticular juvenile idiopathic arthritis.
A biosimilar is a product that is highly similar to an already available reference product, which means it has no clinically meaningful differences in terms of safety and efficacy from the reference product—in this case, Humira, according to the FDA.

Adalimumab-adbm will carry a boxed warning about serious infections and malignancies; other adalimumab products also carry this warning. The serious infectious risks include tuberculosis, bacterial sepsis, invasive fungal infections and other opportunistic infections. The malignancy warning concerns lymphoma and other malignancies, which have been fatal. In addition, the FDA warned that “post marketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma have occurred in adolescents and young adults with inflammatory bowel disease treated with TNF blockers.” 

The most frequently reported adverse events are infections and injection-site reactions.