Last reviewed · How we verify
Simponi (Golimumab)
Simponi (Golimumab) is a TNF-alpha inhibitor Biologic drug developed by Alvotech Swiss AG. It is currently in Phase 3 development for Rheumatoid Arthritis, Psoriatic Arthritis, Ulcerative Colitis.
Simponi (Golimumab) is a monoclonal antibody that selectively binds to and inhibits tumor necrosis factor-alpha (TNF-alpha), a pro-inflammatory cytokine.
Golimumab, also known as Simponi, is a TNF-alpha inhibitor used to treat various conditions, including Axial Spondyloarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriasis, and Psoriatic-arthritis. It is a monoclonal antibody that works by inhibiting the action of tumor necrosis factor, a protein involved in inflammation.
-
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.
| 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 | Simponi (Golimumab) |
|---|---|
| Sponsor | Alvotech Swiss AG |
| Drug class | TNF-alpha inhibitor |
| Target | TNF-alpha |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
By binding to TNF-alpha, Golimumab prevents it from interacting with its receptor on cell surfaces, thereby reducing inflammation and halting disease progression in various conditions. This mechanism of action is central to its therapeutic effects in treating autoimmune diseases.
Approved indications
- Rheumatoid Arthritis
- Psoriatic Arthritis
- Ulcerative Colitis
Common side effects
- Injection site reaction
- Headache
- Fatigue
- Nausea
- Diarrhea
Key clinical trials
- Efficacy of Different Biological Treatments in Patients With Inflammatory Bowel Disease After One Year of Treatment in Upper Egypt
- A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis (PHASE2)
- A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (PHASE3)
- A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis (PHASE2)
- An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis
- Golimumab and Apalutamide for the Treatment of Castration-Resistant Prostate Cancer, TRAMP Study (PHASE2)
- Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population
- Stand UP to Rheumatoid Arthritis (SUPRA) (NA)
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:
- Simponi (Golimumab) CI brief — competitive landscape report
- Simponi (Golimumab) updates RSS · CI watch RSS
- Alvotech Swiss AG portfolio CI
Frequently asked questions about Simponi (Golimumab)
What is Simponi (Golimumab)?
How does Simponi (Golimumab) work?
What is Simponi (Golimumab) used for?
Who makes Simponi (Golimumab)?
What drug class is Simponi (Golimumab) in?
What development phase is Simponi (Golimumab) in?
What are the side effects of Simponi (Golimumab)?
What does Simponi (Golimumab) target?
Related
- Drug class: All TNF-alpha inhibitor drugs
- Target: All drugs targeting TNF-alpha
- Manufacturer: Alvotech Swiss AG — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Rheumatoid Arthritis
- Indication: Drugs for Psoriatic Arthritis
- Indication: Drugs for Ulcerative Colitis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing