Last reviewed 2026-05-31 · How we verify

Stelara (EU-sourced)

Bio-Thera Solutions · Phase 3 active Small molecule ✓ Verified May 2026

Stelara (EU-sourced) is a IL-12/IL-23 inhibitor (monoclonal antibody) Small molecule drug developed by Bio-Thera Solutions. It is currently in Phase 3 development for Moderate to severe plaque psoriasis, Active Crohn's disease, Active ulcerative colitis.

Stelara is a human monoclonal antibody that blocks the IL-12 and IL-23 cytokines to suppress immune-mediated inflammation.

Stelara (EU-sourced) is used to treat moderate to severe plaque psoriasis. It is a treatment option that has been compared to another medication, BAT2206, in clinical trials.

Likelihood of approval

59.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Immunology slight uplift +1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Stelara (EU-sourced)
Sponsor	Bio-Thera Solutions
Drug class	IL-12/IL-23 inhibitor (monoclonal antibody)
Target	IL-12 p40 subunit / IL-23 p40 subunit
Modality	Small molecule
Therapeutic area	Immunology / Gastroenterology / Dermatology
Phase	Phase 3

Mechanism of action

Stelara (ustekinumab) binds to the p40 subunit shared by IL-12 and IL-23, preventing these pro-inflammatory cytokines from activating T cells and other immune cells. This dual inhibition reduces the Th1 and Th17 immune responses that drive autoimmune and inflammatory diseases. The mechanism is particularly effective in conditions where these pathways are pathogenic, such as psoriasis, Crohn's disease, and ulcerative colitis.

Approved indications

Moderate to severe plaque psoriasis
Active Crohn's disease
Active ulcerative colitis
Psoriatic arthritis
Ankylosing spondylitis

Common side effects

Nasopharyngitis
Upper respiratory tract infection
Headache
Fatigue
Injection site reactions

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Stelara (EU-sourced) CI brief — competitive landscape report
Stelara (EU-sourced) updates RSS · CI watch RSS
Bio-Thera Solutions portfolio CI

Frequently asked questions about Stelara (EU-sourced)

What is Stelara (EU-sourced)?

Stelara (EU-sourced) is a IL-12/IL-23 inhibitor (monoclonal antibody) drug developed by Bio-Thera Solutions, indicated for Moderate to severe plaque psoriasis, Active Crohn's disease, Active ulcerative colitis.

How does Stelara (EU-sourced) work?

Stelara is a human monoclonal antibody that blocks the IL-12 and IL-23 cytokines to suppress immune-mediated inflammation.

What is Stelara (EU-sourced) used for?

Stelara (EU-sourced) is indicated for Moderate to severe plaque psoriasis, Active Crohn's disease, Active ulcerative colitis, Psoriatic arthritis, Ankylosing spondylitis.

Who makes Stelara (EU-sourced)?

Stelara (EU-sourced) is developed by Bio-Thera Solutions (see full Bio-Thera Solutions pipeline at /company/bio-thera-solutions).

What drug class is Stelara (EU-sourced) in?

Stelara (EU-sourced) belongs to the IL-12/IL-23 inhibitor (monoclonal antibody) class. See all IL-12/IL-23 inhibitor (monoclonal antibody) drugs at /class/il-12-il-23-inhibitor-monoclonal-antibody.

What development phase is Stelara (EU-sourced) in?

Stelara (EU-sourced) is in Phase 3.

What are the side effects of Stelara (EU-sourced)?

Common side effects of Stelara (EU-sourced) include Nasopharyngitis, Upper respiratory tract infection, Headache, Fatigue, Injection site reactions.

What does Stelara (EU-sourced) target?

Stelara (EU-sourced) targets IL-12 p40 subunit / IL-23 p40 subunit and is a IL-12/IL-23 inhibitor (monoclonal antibody).

Drug class: All IL-12/IL-23 inhibitor (monoclonal antibody) drugs
Target: All drugs targeting IL-12 p40 subunit / IL-23 p40 subunit
Manufacturer: Bio-Thera Solutions — full pipeline
Therapeutic area: All drugs in Immunology / Gastroenterology / Dermatology
Indication: Drugs for Moderate to severe plaque psoriasis
Indication: Drugs for Active Crohn's disease
Indication: Drugs for Active ulcerative colitis

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing