Food and Drug Administration Approves Amjevita, Product Similar to Humira
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Food and Drug Administration Approves Amjevita, Product Similar to Humira

The product is approved to treat numerous inflammatory diseases in adult patients

September 27, 2016

The Food and Drug Administration (FDA) has approved Amjevita as a Humira biosimilar for the treatment of several inflammatory diseases in adult patients.

A biosimilar is a biological product that is approved by the FDA based on high similarity to another FDA-approved biological product and that has no clinically meaningful difference from that product regarding safety, effectiveness, or purity. Biological products usually are derived from living organisms and may have many sources, such as humans, animals, microorganisms, or yeast.

Amjevita is approved to treat the following conditions:

  • 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
  • Moderate to severe plaque psoriasis
  • Moderately-to-severely-active polyarticular juvenile idiopathic arthritis (in patients four years old and older)

Healthcare professionals should examine the prescribing information located in the product label for details regarding the approved uses of the product.

"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," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research.

The FDA approved Amjevita based on its review of evidence including structural and functional characterization, data from animal studies, data from human pharmacokinetics and pharmacodynamics, clinical immunogenicity data, and other data regarding the clinical safety and effectiveness of the product that indicates its biosimilarity to Humira. Although Amjevita has been approved as a biosimilar, it has not been approved as an interchangeable product.

Infections and malignancies are the most serious known side effects of Amjevita. The most common are infections and reactions at the injection site.

Amjevita's labeling, like that of Humira, contains a Boxed Warning intended to alert healthcare professionals and patients to a higher risk of serious infections that could lead to hospitalization or death. It also points out that malignancies such as lymphoma—some fatal—have been reported in child and adolescent patients who were treated with tumor necrosis factor blockers, such as adalimumab products. A patient Medication Guide describing important information about the uses and risks of Amjevita must be dispensed along with the product.