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GP2017 Adalimumab
GP2017 Adalimumab is a TNF-α inhibitor (monoclonal antibody biosimilar) Small molecule drug developed by Sandoz. It is currently in Phase 3 development for Rheumatoid arthritis, Crohn's disease, Ulcerative colitis.
GP2017 is a biosimilar of adalimumab that blocks tumor necrosis factor-alpha (TNF-α) to reduce inflammation and immune-mediated disease activity.
GP2017 Adalimumab is a biosimilar of Humira, an antibody that inhibits tumor necrosis factor, a protein involved in inflammation. It has been studied in clinical trials for the treatment of plaque type psoriasis, ankylosing spondylitis, and rheumatoid arthritis.
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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 | GP2017 Adalimumab |
|---|---|
| Sponsor | Sandoz |
| Drug class | TNF-α inhibitor (monoclonal antibody biosimilar) |
| Target | TNF-α (tumor necrosis factor-alpha) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
As an adalimumab biosimilar, GP2017 is a fully human monoclonal antibody that binds to and neutralizes TNF-α, a key pro-inflammatory cytokine. By inhibiting TNF-α signaling, it suppresses the inflammatory cascade underlying autoimmune and inflammatory conditions. This mechanism is identical to the reference adalimumab product.
Approved indications
- Rheumatoid arthritis
- Crohn's disease
- Ulcerative colitis
- Psoriasis
- Ankylosing spondylitis
- Other TNF-α-mediated inflammatory conditions
Common side effects
- Injection site reactions
- Upper respiratory tract infections
- Headache
- Serious infections (tuberculosis, opportunistic infections)
- Malignancy risk
Key clinical trials
- Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar) (PHASE3)
- Clinical Trial to Compare Treatment With GP2017 and Humira® in Patients With Rheumatoid Arthritis (PHASE3)
- Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Adalimumab (GP2017) and Humira (PHASE3)
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:
- GP2017 Adalimumab CI brief — competitive landscape report
- GP2017 Adalimumab updates RSS · CI watch RSS
- Sandoz portfolio CI
Frequently asked questions about GP2017 Adalimumab
What is GP2017 Adalimumab?
How does GP2017 Adalimumab work?
What is GP2017 Adalimumab used for?
Who makes GP2017 Adalimumab?
What drug class is GP2017 Adalimumab in?
What development phase is GP2017 Adalimumab in?
What are the side effects of GP2017 Adalimumab?
What does GP2017 Adalimumab target?
Related
- Drug class: All TNF-α inhibitor (monoclonal antibody biosimilar) drugs
- Target: All drugs targeting TNF-α (tumor necrosis factor-alpha)
- Manufacturer: Sandoz — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Rheumatoid arthritis
- Indication: Drugs for Crohn's disease
- Indication: Drugs for Ulcerative colitis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing