FDA OKs Biosimilar to Adalimumab for Inflammatory Diseases

Troy Brown, RN


September 23, 2016

The US Food and Drug Administration (FDA) has approved adalimumab-atto (Amjevita, Amgen, Inc), a biosimilar to adalimumab (Humira, AbbVie, Inc; approved in December 2002), for the treatment of multiple inflammatory diseases.

The biosimilar is 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-atto is approved for children aged 4 years or older with moderately to severely active polyarticular juvenile idiopathic arthritis.

"This is the fourth FDA-approved biosimilar. The biosimilar pathway is still a new frontier and one that we expect will enhance access to treatment for patients with serious medical conditions," Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said in an FDA news release.

A biosimilar is a drug that has been demonstrated to be highly similar to another approved drug with no clinically meaningful differences in "safety, purity and potency," the FDA explained.

The FDA's approval follows a review of data including structural and functional analyses, animal study data, human pharmacokinetic and pharmacodynamics analyses, and clinical immunogenicity data, as well as clinical safety and effectiveness data supporting the drug's biosimilarity to adalimumab.

The FDA has approved adalimumab-atto as a biosimilar and not as an interchangeable drug.

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

Boxed Warning for Serious Infections, Malignancies

As with adalimumab, adalimumab-atto has a boxed warning about increased risk for serious and sometimes fatal infections. The boxed warning also cautions that lymphoma and other, sometimes fatal, malignancies have occurred in children and adolescents treated with tumor necrosis factor blockers, including adalimumab products. The FDA requires adalimumab-atto to be dispensed with a patient medication guide that provides important information about the drug's uses and risks.

Healthcare professionals should familiarize themselves with the label's prescribing information about the approved indications.

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