Green Light for Biosimilar to Humira

Amjevita (adalimumab-atto), from Amgen, approved to treat multiple inflammatory diseases

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(RxWiki News) The US Food and Drug Administration has approved its fourth biosimilar.

This biosimilar is Amgen's Amjevita (adalimumab-atto). Adalimumab-atto is biosimilar to Humira (adalimumab) and is available as an injection given under the skin. It was approved to treat several inflammatory diseases.

These inflammatory diseases include rheumatoid arthritis, psoriatic arthritis, arthritis that affects the spine (referred to as ankylosing spondylitis), Crohn’s disease, ulcerative colitis and plaque psoriasis.

This new biosimilar has also been approved to treat a common type of arthritis that affects five or more joints in children. This type of arthritis is referred to as polyarticular juvenile idiopathic arthritis.

Common side effects of adalimumab-atto include headaches; injection-site reactions like redness, rash, itching, swelling or bruising; and upper respiratory infections like sinus infections.

This medication carries a boxed warning regarding an increased risk for serious infections. In addition, there have been reports of lymphoma or other cancers in children and adolescent patients treated with tumor necrosis factor blockers, which include adalimumab-atto. 

If you have an inflammatory disease, speak to your doctor about the best treatment option for you. 

Last Updated:
September 27, 2016