Two medicines, side by side
Adalimumab vs ustekinumab
Adalimumab and ustekinumab are both labeled for crohn's disease and ulcerative colitis. Drugs@FDA records approvals of adalimumab since 2002 and of ustekinumab since 2009. Pharmacies paid $1,587.82 per mL (Adalimumab-adaz(cf) pen 40 mg/0.4 mL) and $29,874.45 per mL (Stelara 45 mg/0.5 mL syringe) (NADAC, October 7, 2026); the strengths differ and one is a brand and one a generic, so the two prices are not like for like. In FDA's classes, adalimumab is a tumor necrosis factor blocker and ustekinumab an interleukin-12 antagonist.
Check it at the source: the adalimumab FDA label on DailyMed (effective October 21, 2025); the ustekinumab FDA label on DailyMed (effective September 8, 2026).
Highlights of the adalimumab record
Adalimumab (Humira) · label of October 21, 2025
SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products, including Adalimumab-adaz, 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 Adalimumab-adaz if a patient develops a serious infection or sepsis.
Used for
From the label: indicationsAdalimumab-adaz 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. […]
On the market
- Earliest approval on file
- December 31, 2002
- Generic labelers
- none listed
- Pharmacy cost
- $1,587.82 per mL
Supply and safety
- Shortage
- No current entry
- Recalls
- 1
Highlights of the ustekinumab record
Ustekinumab (Stelara) · label of September 8, 2026
Used for
From the label: indicationsSTELARA is a human interleukin-12 and -23 antagonist indicated for the treatment of: Moderate to severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. ( 1.1 ) Active psoriatic arthritis in adults and pediatric patients 6 years of age and older. […]
On the market
- Earliest approval on file
- September 25, 2009
- Generic labelers
- none listed
- Pharmacy cost
- $29,874.45 per mL
Supply and safety
- Shortage
- No current entry
- Recalls
- 0
Source: FDA drug labels via openFDA (Adalimumab label of October 21, 2025, Ustekinumab label of September 8, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do adalimumab and ustekinumab differ on the record?
In FDA's classes, adalimumab is a tumor necrosis factor blocker and ustekinumab an interleukin-12 antagonist.
How each works, in its label's words: Adalimumab, “Adalimumab products bind specifically to TNF-alpha and block its interaction with the p55 and p75 cell surface TNF receptors.”; Ustekinumab, “Ustekinumab is a human IgG1қ monoclonal antibody that binds with specificity to the p40 protein subunit used by both the IL-12 and IL-23 cytokines.”
Half-life, in each label's words: Adalimumab, “The mean terminal half-life was approximately 2 weeks, ranging from 10 to 20 days across studies.”; Ustekinumab, “Elimination The mean (±SD) half-life ranged from 14.9 ± 4.6 to 45.6 ± 80.2 days across all trials in subjects with …”
Only the adalimumab label carries a boxed warning.
| Adalimumab | Ustekinumab | |
|---|---|---|
| Labeled for | Rheumatoid arthritis, Crohn's disease and ulcerative colitis, Psoriasis | Crohn's disease and ulcerative colitis |
| Pharmacologic class | Tumor Necrosis Factor Blocker | Interleukin-12 Antagonist, Interleukin-23 Antagonist |
| How it works (label) | Adalimumab products bind specifically to TNF-alpha and block its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab products also lyse surface TNF expressing cells in vitro in the presence of complement. | Ustekinumab is a human IgG1қ monoclonal antibody that binds with specificity to the p40 protein subunit used by both the IL-12 and IL-23 cytokines. |
| Half-life (label) | The mean terminal half-life was approximately 2 weeks, ranging from 10 to 20 days across studies. | Elimination The mean (±SD) half-life ranged from 14.9 ± 4.6 to 45.6 ± 80.2 days across all trials in subjects with plaque psoriasis following subcutaneous administration. |
| Earliest approval on file (Drugs@FDA) | December 31, 2002 | September 25, 2009 |
| First generic approved | none | none |
| Generic labelers (NDC) | none listed | none listed |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $1,587.82 per mL (Adalimumab-adaz(cf) pen 40 mg/0.4 mL) | $29,874.45 per mL (Stelara 45 mg/0.5 mL syringe) |
| 12-month price change | -0.3% | +5% |
| Boxed warning | Yes | No |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 1 | 0 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 712,308 | 102,257 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
What next?
- Alternatives to adalimumab
- every medicine labeled for the same conditions