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Adalimumab biosimilar
Adalimumab biosimilar is a TNF-alpha inhibitor Biologic drug developed by Alvotech Swiss AG. It is currently in Phase 3 development for Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis. Also known as: AVT02.
Adalimumab biosimilar is a TNF-alpha inhibitor that binds to and neutralizes tumor necrosis factor-alpha, reducing inflammatory signaling.
Adalimumab biosimilar, also known as GP2017 Adalimumab, is a monoclonal antibody that works by inactivating tumor necrosis factor, a protein involved in inflammation. It is used to treat various chronic inflammatory diseases, including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
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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 | Adalimumab biosimilar |
|---|---|
| Also known as | AVT02 |
| Sponsor | Alvotech Swiss AG |
| Drug class | TNF-alpha inhibitor |
| Target | TNF-alpha (Tumor Necrosis Factor-alpha) |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Adalimumab is a fully human monoclonal antibody that binds with high affinity to soluble and membrane-bound TNF-alpha, preventing its interaction with TNF receptors on immune cells. This blocks the inflammatory cascade driven by TNF-alpha, reducing systemic inflammation and immune activation in autoimmune and inflammatory conditions. As a biosimilar, it is a highly similar version of the reference biologic adalimumab (Humira) with comparable efficacy and safety.
Approved indications
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn's disease
- Ulcerative colitis
- Plaque psoriasis
- Hidradenitis suppurativa
Common side effects
- Injection site reactions
- Upper respiratory tract infections
- Headache
- Tuberculosis reactivation
- Serious infections
- Malignancy risk
Key clinical trials
- Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis (PHASE3)
- Preventing Structural Damage in Early Psoriatic Arthritis (PHASE4)
- The Evaluation of Injection Site Pain and Adherence in Patients Switching From a Low To High Concentration Adalimumab (AVT-02) Across Multiple Indications.
- Clinical Study of Stage IV Psoriasis in Children With Geleli
- Observational Study, to Assess Treatment Retention of an Adalimumab Biosimilar (Hyrimoz®) in IBD Patients in Real Life Setting
- A Trial of Academic Detailing to Promote Prescribing of Biosimilars (NA)
- Multicenter Randomized Double Blind Controlled-study to Assess the Potential of Methotrexate Versus Placebo to Improve and Maintain Response to Anti TNF- Alpha Agents in Adult Patients With Moderate to Severe Psoriasis (PHASE4)
- SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY)
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:
- Adalimumab biosimilar CI brief — competitive landscape report
- Adalimumab biosimilar updates RSS · CI watch RSS
- Alvotech Swiss AG portfolio CI
Frequently asked questions about Adalimumab biosimilar
What is Adalimumab biosimilar?
How does Adalimumab biosimilar work?
What is Adalimumab biosimilar used for?
Who makes Adalimumab biosimilar?
Is Adalimumab biosimilar also known as anything else?
What drug class is Adalimumab biosimilar in?
What development phase is Adalimumab biosimilar in?
What are the side effects of Adalimumab biosimilar?
What does Adalimumab biosimilar target?
Related
- Drug class: All TNF-alpha inhibitor drugs
- Target: All drugs targeting TNF-alpha (Tumor Necrosis Factor-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 Ankylosing spondylitis
- Also known as: AVT02
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing