These highlights do not include all the information needed to use AMJEVITA safely and effectively. See full prescribing information for AMJEVITA. AMJEVITA® (adalimumab-atto) injection, for subcutaneous use Initial U.S. Approval: 2016 AMJEVITA (adalimumab-atto) is biosimilarBiosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of AMJEVITA has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information. to HUMIRA® (adalimumab).

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These highlights do not include all the information needed to use AMJEVITA safely and effectively. See full prescribing information for AMJEVITA. AMJEVITA® (adalimumab-atto) injection, for subcutaneous use Initial U.S. Approval: 2016 AMJEVITA (adalimumab-atto) is biosimilarBiosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of AMJEVITA has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information. to HUMIRA® (adalimumab).

Medication label

Why this: Advisory · dailymed-prescription

AMJEVITA is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. AMJEVITA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). AMJEVITA is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. AMJEVITA can be used alone or in combination with methotrexate. AMJEVITA is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. AMJEVITA can be used alone or in combination with non-biologic DMARDs. AMJEVITA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. AMJEVITA is indicated for the treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. AMJEVITA is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF-blockers [see Clinical Studies (14.7)]. AMJEVITA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. AMJEVITA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Boxed Warning and Warnings and Precautions (5)]. AMJEVITA is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. AMJEVITA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.

generic_name: adalimumab-atto
product_names: adalimumab-atto
ndc: 84612-399, 84612-399-01, 84612-479, 84612-479-02, 84612-479-01, 84612-482, 84612-482-02, 84612-482-01, 84612-481, 84612-481-02, 84612-481-01
group: drugs
license: us-gov-pd
attribution: Courtesy of the National Library of Medicine
reviewed: 2026-09-18
language: en