HULIO (adalimumab-fkjp) · Viatris
HULIO (adalimumab-fkjp) is a tumor necrosis factor (TNF) blocker indicated for the treatment of several chronic inflammatory and autoimmune conditions in adult and pediatric populations. It is used to manage joint-related diseases such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, as well as gastrointestinal disorders like Crohn’s disease and ulcerative colitis. The therapy is also approved for dermatological conditions including plaque psoriasis and hidradenitis suppurativa, and for non-infectious uveitis. Its effectiveness has not been established in patients who have previously lost response to or were intolerant to other TNF blockers.
How HULIO Works
HULIO functions by specifically binding to TNF-alpha, a naturally occurring cytokine that drives inflammatory and immune responses. By binding to this cytokine, the drug blocks its interaction with the p55 and p75 cell surface receptors, thereby inhibiting the pathological inflammation and tissue destruction associated with elevated TNF levels. Additionally, the medication can lyse cells that express TNF on their surface and modulate biological responses such as the concentration of adhesion molecules responsible for leukocyte migration.
Details
- Status
- Prescription
- First Approved
- 2020-07-06
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
HULIO Approval History
What HULIO Treats
9 indicationsHULIO is approved for 9 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
HULIO Boxed Warning
SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products including HULIO 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 HULIO if a patient develops a serious infection or sepsis. Reported infections include: • Active tuberculosis ...
WARNING: SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products including HULIO 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 HULIO 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 HULIO use and during therapy. Initiate treatment for latent TB prior to HULIO 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 HULIO 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 HULIO, 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 Warnings and
HULIO 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 HULIO for Humira without calling the prescriber. This is a lower-cost alternative with no clinically meaningful differences.
HULIO 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 HULIO's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications HULIO treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to HULIO
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Viatris's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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.
HULIO FDA Label Details
Indications & Usage
FDA Label (PDF)HULIO is a tumor necrosis factor (TNF) blocker indicated for: Rheumatoid Arthritis (RA) : 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 RA. J uvenile Idiopathic Arthritis (JIA) : reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. Psoriatic Arthritis (PsA) : reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patien...
WARNING: SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products including HULIO 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 infectio...
Explore on TheraRadar
Crohn's Disease Drug Landscape 2026
Approved therapies, pipeline drugs, and clinical trial intelligence
Related Intelligence
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.