YUSIMRY
YUSIMRY (adalimumab-aqvh) is a tumor necrosis factor (TNF) blocker indicated for the treatment of several chronic inflammatory and autoimmune conditions in adult and pediatric patients. The therapy is used to manage joint-related disorders such as rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, and ankylosing spondylitis. It is also approved for the treatment of gastrointestinal diseases, including Crohn’s disease and ulcerative colitis, as well as specific dermatological and ophthalmic conditions. Its therapeutic role involves reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in affected patients.
How YUSIMRY Works
YUSIMRY functions by specifically binding to TNF-alpha, a naturally occurring cytokine that drives inflammatory and immune responses. By binding to TNF-alpha, the drug blocks its interaction with the p55 and p75 cell surface TNF receptors, thereby neutralizing its biological activity. This mechanism also results in the lysis of surface TNF-expressing cells and the modulation of adhesion molecules responsible for leukocyte migration. In patients with psoriasis, this activity may reduce epidermal thickness and the infiltration of inflammatory cells.
Details
- Status
- Prescription
- First Approved
- 2021-12-17
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
YUSIMRY Approval History
What YUSIMRY Treats
9 indicationsYUSIMRY is approved for 9 conditions since its original approval in 2021. 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
- Chronic Plaque Psoriasis
- Hidradenitis Suppurativa
YUSIMRY Boxed Warning
SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products including YUSIMRY 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 YUSIMRY if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculos...
WARNING: SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products including YUSIMRY 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 YUSIMRY 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 YUSIMRY use and during therapy. Initiate treatment for latent TB prior to YUSIMRY 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 YUSIMRY 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 YUSIMRY, 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 products [see Wa
YUSIMRY 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.
YUSIMRY is a lower-cost alternative to Humira with no clinically meaningful differences. Requires prescriber approval to substitute.
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Active Pipeline
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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.
YUSIMRY FDA Label Details
ProIndications & Usage
FDA Label (PDF)YUSIMRY 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 si...
WARNING: SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products including YUSIMRY 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 infec...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.