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The U.S. Food and Drug Administration today approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases.
Amjevita is approved for the following indications in adult patients:
- moderately to severely active rheumatoid arthritis;
- active psoriatic arthritis;
- active ankylosing spondylitis (an arthritis that affects the spine);
- moderately to severely active Crohn’s disease;
- moderately to severely active ulcerative colitis; and
- moderate to severe plaque psoriasis.
Amjevita is also indicated for moderately to severely active polyarticular juvenile idiopathic arthritis in patients four years of age and older.
The most serious known side effects with Amjevita are infections and malignancies. The most common expected adverse reactions with Amjevita are infections and injection site reactions.
Like Humira, the labeling for 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. The drug must be dispensed with a patient Medication Guide that describes important information about its uses and risks.
For more information, please visit: Amjevita.