FDA Approves Second Humira Biosimilar, Cyltezo

Megan Brooks

August 25, 2017

The US Food and Drug Administration (FDA) has approved adalimumab-adbm (Cyltezo, Boehringer Ingelheim) for multiple indications.

Cyltezo is a biosimilar of AbbVie's Humira (adalimumab). Cyltezo is administered by subcutaneous injection (40 mg/0.8 mL).

This is the second FDA-approved biosimilar to Humira; adalimumab-atto (Amjevita, Amgen, Inc) was the first, approved in September 2016, as reported by Medscape Medical News.

Cyltezo is a tumor necrosis factor (TNF) 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's disease, moderately to severely active ulcerative colitis, and moderate-to-severe plaque psoriasis.

In addition, adalimumab-adbm is approved for children aged 4 years or older with moderately to severely active polyarticular juvenile idiopathic arthritis.

According to the FDA, a biosimilar is a drug that has been demonstrated to be "highly similar" to the already-approved reference product. "The biosimilar also must be shown to have no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products," they explain.

The most serious known adverse events associated with adalimumab-adbm are infections and malignancies. The most frequently expected adverse events are infections and injection-site reactions.

As with adalimumab, adalimumab-adbm has a boxed warning about increased risk for serious and sometimes fatal infections. The warning also cautions that lymphoma and other, sometimes fatal, malignancies have occurred in children and adolescents treated with TNF inhibitors, including adalimumab products.

The full prescribing information is available online.

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