Amgen has announced that the US Food and Drug Administration (FDA) has approved Amjevita (adalimumab-atto) across all eligible indications of the reference product, Humira (adalimumab). Amjevita is the first adalimumab biosimilar approved by the FDA and is Amgen's first biosimilar to receive regulatory approval.

Indications: Amjevita has been approved for the treatment of 7 inflammatory diseases, including moderate-to-severe rheumatoid arthritis, moderate-to-severe polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, moderate-to-severe chronic plaque psoriasis, adult moderate-to-severe Crohn's disease, and moderate-to-severe ulcerative colitis.

Dosage/administration: Amjevita is administered by subcutaneous injection. Dosage is based on disease state and/or body weight. Additional information can be found at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761024lbl.pdf.

Adverse reactions: The most common adverse reactions in adalimumab clinical trials (>10%) were infections (eg, upper respiratory, sinusitis), injection site reactions, headache, and rash.