YUFLYMA (adalimumab-aaty) · CELLTRION INC
YUFLYMA is a tumor necrosis factor (TNF) blocker indicated for the treatment of several chronic inflammatory and autoimmune diseases in adult and pediatric populations. It is used to reduce signs and symptoms, inhibit the progression of structural damage, and improve physical function in conditions such as rheumatoid arthritis and psoriatic arthritis. The medication is also approved for gastrointestinal, dermatological, and ophthalmic conditions, including Crohn's disease, plaque psoriasis, and uveitis. Its effectiveness has not been established in patients who have lost response to or were intolerant to other TNF blockers.
How YUFLYMA Works
YUFLYMA binds specifically to TNF-alpha, a naturally occurring cytokine involved in inflammatory and immune responses. By blocking TNF-alpha's interaction with p55 and p75 cell surface receptors, the drug inhibits the pathological inflammation and joint destruction associated with elevated TNF levels. It also lyses cells that express surface TNF and modulates biological responses, such as the concentration of adhesion molecules responsible for leukocyte migration.
Details
- Status
- Prescription
- First Approved
- 2023-05-23
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
YUFLYMA Approval History
What YUFLYMA Treats
9 indicationsYUFLYMA is approved for 9 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
YUFLYMA Boxed Warning
SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. SERIOUS INFECTIONS ( 5.1 , 6.1 ): Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. Discontinue YUFLYMA if a patient develops a serious infection or sepsis during treatment. Perform tes...
WARNING: SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. SERIOUS INFECTIONS ( 5.1 , 6.1 ): Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. Discontinue YUFLYMA if a patient develops a serious infection or sepsis during treatment. Perform test for latent TB; if positive, start treatment for TB prior to starting YUFLYMA. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. MALIGNANCY ( 5.2 ): Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers including adalimumab products. SERIOUS INFECTIONS Patients treated with adalimumab products, including YUFLYMA, 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 YUFLYMA 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 YUFLYMA use and during therapy. Initiate treatment for latent TB prior to YUFLYMA use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive f
YUFLYMA 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 YUFLYMA for Humira without calling the prescriber. This is a lower-cost alternative with no clinically meaningful differences.
YUFLYMA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in YUFLYMA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications YUFLYMA treats. First-in-class if their pivotal trials read out positive.
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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.
YUFLYMA FDA Label Details
Indications & Usage
FDA Label (PDF)YUFLYMA 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 r heumatoid 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 p soriatic arthritis . Reducing ...
WARNING: SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. SERIOUS INFECTIONS ( 5.1 , 6.1 ): Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.