Humira adalimumab APPROVED
Drug Profile
ModalityAntibody
RouteSC
Therapy AreaImmunology
Launch2002-12-31
US LOE2023-01-31
Peak Sales Est$21000M
Formulations[{"id":"humira-sc","route":"SC","device":"Pre-filled pen or syringe","setting":"PATIENT_SELF","frequ
Companies
ABBV (ORIGINATOR)100%
Mechanism: TNF inhibitor
Expert: Tumor necrosis factor alpha inhibitor that binds and neutralizes TNF-α, reducing inflammatory signaling. Cimzia is pegylated for extended half-life.
Everyday: Blocks TNF, a protein that causes inflammation in autoimmune diseases.
Targets: ["TNF"]
Revenue History
PeriodRevenue ($M)
2024$8,975M
2025$4,540M
Q4 2025$980M
2023$14,400M
Q1 2025$1,121M
Programs (2)
IndicationStageKey StudyRegional Status
RAAPPROVEDMultiple Phase 3[{"stage":"APPROVED","region":"US","approval_date":"2002-12-31"},{"stage":"APPRO
PsOAPPROVEDREVEAL[{"stage":"APPROVED","region":"US","approval_date":"2008-01-18"}]
Notes
TNF-alpha inhibitor. Legacy standard of care for psoriasis and many autoimmune diseases. PASI 90 ~45% Wk16. Beaten by every newer class in H2H trials. Peak revenue $20.7B (2021) — highest-selling drug in history. US biosimilars launched Jan 2023 (10 approved). Revenue declining steeply: $14.4B (2023) → $8.99B (2024) → $4.54B (2025). In psoriasis, now rarely used first-line given IL-23 and IL-17 class superiority. Still used in other indications (RA, IBD) where biosimilar switching is slower.
Safety Profile
{"keyRisks":[{"category":"Infections","description":"Serious infections including TB, invasive fungal infections"},{"category":"Malignancy","description":"Lymphoma and other malignancies, especially in children/adolescents"},{"category":"HBV Reactivation","description":"Hepatitis B virus reactivation"}],"monitoring":["TB screening","HBV screening"],"labelSource":"FDA PI 2024","classWarnings":["TNF inhibitor class warning"],"hasBoxedWarning":true,"boxedWarningText":"SERIOUS INFECTIONS AND MALIGNANCY","contraindications":["Active serious infections"],"boxedWarningCategories":["Infections","Malignancy"]}
Data from Supabase · Updated 2026-03-24