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Adalimumab-atto will be used to treat several inflammatory diseases, including rheumatoid arthritis, plaque psoriasis, and psoriatic arthritis.
Adalimumab-atto (Amjevita), a new biosimilar to adalimumab (Humira), a treatment commonly prescribed to patients with inflammatory diseases including rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis, is now available.
The originator drug is an anti-tumor necrosis factor (anti-TNF) monoclonal antibody currently approved for the treatment of moderate-to-severe rheumatoid arthritis in adults, moderate-to-severe polyarticular juvenile idiopathic arthritis in patients 2 years of age and older, psoriatic arthritis in adults, ankylosing spondylitis in adults, moderate-to-severe chronic plaque psoriasis in adults, moderate-to-severe Crohn's disease in adults and pediatric patients 6 years of age and older and moderate-to-severe ulcerative colitis in adults.
The FDA’s approval for adalimumab-atto is earmarked for several indications, including the reduction of signs and symptoms inhibiting structural damage and improving physical function for adults with moderately to severely active rheumatoid arthritis, alone or as a combination therapy with methotrexate of other non-biologic disease-modifying antirheumatic drugs (DMARDs).
The biosimilar will also be used alone or in combination with methotrexate for the treatment of moderately to severely active polyarticular juvenile idiopathic arthritis in patients aged 2 years or older and for the treatment of adult patients with active psoriatic arthritis.
Finally, the drug is indicated for adult patients with active ankylosing spondylitis, severely active Crohn’s disease for patients aged 6 years or old, adults with ulcerative colitis, and adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.
The approval was awarded to Amgen and will be available at a price 55% below the current price of adalimumab.
The biosimilar will be available in prefilled syringe and autoinjector presentations based on the specific dosing regimen.
"Biosimilars are extensively studied, FDA-approved treatments that have the potential to reduce costs to the healthcare system," said Steven Taylor, president and chief executive officer at the Arthritis Foundation, in a statement. "AMJEVITA provides another treatment option for patients and their doctors."