FDA Approves Amjevita, First Biosimilar Adalimumab

September 26, 2016

Biosimilars Team

The Food and Drug Administration (FDA) has approved Amjevita (adalimumab-atto; Amgen, Inc.) for the treatment of multiple inflammatory diseases. Amjevita is a biosimilar to Humira (adalimumab; AbbVie Inc.), which was licensed in 2002. Amjevita has not been approved as an interchangeable product.

Amjevita is a tumor necrosis factor (TNF) blocker that binds specifically to TNF-alpha. It is administered by subcutaneous injection. Amjevita is approved for seven indications included in the reference product label:

  • Moderately to severely active rheumatoid arthritis in adults.
  • Active psoriatic arthritis in adults.
  • Active ankylosing spondylitis in adults.
  • Moderately to severely active Crohn’s disease in adults.
  • Moderately to severely active ulcerative colitis in adults.
  • Moderate to severe plaque psoriasis in adults.
  • Moderately to severely active polyarticular juvenile idiopathic arthritis in patients 4 years of age and older.

Amgen did not seek approval for several additional indications that currently are protected by orphan drug exclusivity. Detailed information about Amjevita approved uses is provided in the full prescribing information.

Like Humira, Amjevita contains a Boxed Warning to alert health care professionals and patients about an increased risk of serious infections leading to hospitalization or death. The Boxed Warning also notes that lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor blockers, including adalimumab products. Amjevita must be dispensed with a patient Medication Guide that describes important information about its uses and risks.