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These highlights do not include all the information needed to use SIMLANDI safely and effectively. See full prescribing information for SIMLANDI. SIMLANDI® (adalimumab-ryvk) injection, for subcutaneous use Initial U.S. Approval: 2024 SIMLANDI (adalimumab-ryvk) 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 SIMLANDI 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 labelWhy this: Advisory · dailymed-prescription
SIMLANDI 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. SIMLANDI can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). SIMLANDI is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. SIMLANDI can be used alone or in combination with methotrexate. SIMLANDI is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. SIMLANDI can be used alone or in combination with non-biologic DMARDs. SIMLANDI is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. SIMLANDI is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. SIMLANDI 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)]. SIMLANDI 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. SIMLANDI should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Warnings and Precautions (5)]. SIMLANDI is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. SIMLANDI is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.
- generic_name
- adalimumab-ryvk
- brand_name
- isopropyl alcohol
- product_names
- adalimumab-ryvk, isopropyl alcohol
- ndc
- 51759-402, 51759-402-02, 51759-402-17, 51759-513, 51759-513-21, 65517-0002, 65517-0002-1, 51759-386, 51759-386-22, 51759-497, 51759-497-31, 51759-412, 51759-412-22, 51759-624, 51759-624-31, 51759-523, 51759-523-21, 51759-634, 51759-634-31, 51759-274, 51759-274-17
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en