SIMLANDI
SIMLANDI (adalimumab-ryvk) is a tumor necrosis factor (TNF) blocker approved for the treatment of several chronic inflammatory and autoimmune conditions in adult and pediatric patients. It is indicated to reduce signs and symptoms, inhibit the progression of structural damage, and improve physical function in various types of arthritis and ankylosing spondylitis. The medication is also used to manage gastrointestinal diseases such as Crohn’s disease and ulcerative colitis, as well as specific dermatological and ophthalmic conditions.
How SIMLANDI Works
SIMLANDI binds specifically to TNF-alpha, a naturally occurring cytokine that plays a key role in inflammatory and immune responses. By binding to TNF-alpha, the drug blocks its interaction with p55 and p75 cell surface receptors, thereby inhibiting the pathological inflammation and tissue destruction associated with elevated TNF levels. Additionally, the drug can lyse cells expressing surface TNF and modulate biological responses, such as the levels of adhesion molecules responsible for leukocyte migration.
Details
- Status
- Prescription
- First Approved
- 2024-02-23
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
SIMLANDI Approval History
What SIMLANDI Treats
9 indicationsSIMLANDI is approved for 9 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Rheumatoid Arthritis
- Juvenile Idiopathic Arthritis
- Psoriatic Arthritis
- Ankylosing Spondylitis
- Crohn’s Disease
- Ulcerative Colitis
- Plaque Psoriasis
- Hidradenitis Suppurativa
SIMLANDI Boxed Warning
SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products, including SIMLANDI, are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 ) ] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue SIMLANDI if a patient develops a serious infection or sepsis. Reported infections include: Active tuber...
WARNING: SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products, including SIMLANDI, are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 ) ] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue SIMLANDI if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before SIMLANDI use and during therapy. Initiate treatment for latent TB prior to SIMLANDI use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria. Carefully consider the risks and benefits of treatment with SIMLANDI prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with SIMLANDI, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )] . MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab product
SIMLANDI Target & Pathway
ProTarget
A pro-inflammatory cytokine that plays a central role in immune responses and inflammation. Excess TNF contributes to autoimmune diseases like rheumatoid arthritis, psoriasis, and inflammatory bowel disease. Blocking TNF reduces inflammation and prevents tissue damage.
Pharmacists can substitute SIMLANDI for Humira without calling the prescriber. This is a lower-cost alternative with no clinically meaningful differences.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SIMLANDI FDA Label Details
ProIndications & Usage
FDA Label (PDF)SIMLANDI is a tumor necrosis factor (TNF) blocker 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 . Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis . Reducing s...
WARNING: SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products, including SIMLANDI, are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 ) ] . Most patients who developed these i...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.