TNF Inhibitors & Biosimilars
21 drugsAbout TNF
Tumor Necrosis Factor (TNF), also known as TNF-alpha, is a potent inflammatory cytokine involved in systemic inflammation and autoimmune diseases.
TNF is a crucial drug target with moderate genetic support (max score 0.30) linking it to systemic lupus erythematosus. Genetic associations and eQTL/pQTL signals support targeting TNF for immune-mediated diseases.
With 21 FDA-approved drugs including HUMIRA, REMICADE, and SIMLANDI, TNF is primarily targeted by biologics (71%), antibodies (19%), and fusion proteins (10%). Top companies include IMMUNEX, Johnson & Johnson, and AbbVie.
TNF Genetic Evidence Moderate
Genetic evidence provides moderate support for TNF as a target, with a max score of 0.30.
Further research into the genetic associations may reveal novel therapeutic strategies.
Evidence Across Diseases
1 totalGWAS and other genetic studies link TNF to 1 diseases.
🔗 Colocalization Evidence 20 strong
max H4: 1.00eQTL/pQTL signals for TNF colocalize with these GWAS traits, providing causal evidence that gene expression changes drive disease risk.
Understanding these scores
Association Score (0-1): Combines all evidence types (genetic, literature, drugs, animal models). Higher = more evidence linking target to disease. This is a ranking heuristic, not a confidence score.
L2G Score: Open Targets uses a machine learning model (Locus-to-Gene) to predict which gene is causal at each GWAS locus. L2G=0.5 means ~50% probability of being the causal gene. Only associations with L2G > 0.05 are included.
Odds Ratio (OR): From gene burden studies (UK Biobank, AstraZeneca PheWAS). Measures how loss-of-function variants affect disease risk. OR<1 = protective (inhibiting target may help), OR>1 = risk (losing function causes disease).
Beta (β): Effect size for continuous traits. β<0 = protective, β>0 = risk.
Clinical Translation (~1.8x): Based on Nelson et al. 2015: drug targets with genetic evidence have ~2x higher success rates in clinical trials. We estimate: Strong support (score ≥0.7) → ~1.8x, Moderate (0.3-0.7) → ~1.3x, Weak → baseline.
Colocalization (H4): Tests whether a GWAS signal and an eQTL/pQTL signal share the same causal variant. H4 is the posterior probability that both traits are associated AND share a causal variant. H4 > 0.8 = strong evidence that gene expression/protein levels drive disease risk. This links genetic variation → gene expression → disease, supporting the target-disease connection.
Top TNF Drugs
The TNF market is competitive, with 15 companies holding approved drugs.
A focused strategy targeting specific patient populations may improve market entry.
| Drug | Company | Approved | Indications |
|---|---|---|---|
| AMJEVITA | Amgen | 2016 | 9 |
| SIMLANDI | ALVOTECH USA INC | 2024 | 9 |
| HADLIMA | SAMSUNG BIOEPIS CO LTD | 2019 | 9 |
| HYRIMOZ | Novartis | 2018 | 9 |
| YUFLYMA | CELLTRION INC | 2023 | 9 |
| YUSIMRY | EMERGE BIOSCIENCE PTE LTD | 2021 | 9 |
| IDACIO | Fresenius Kabi | 2022 | 8 |
| REMICADE | Johnson & Johnson | 1998 | 8 |
| HULIO | Viatris | 2020 | 8 |
| CIMZIA | UCB INC | 2008 | 7 |
| ENBREL | IMMUNEX | 1998 | 6 |
| SIMPONI | Johnson & Johnson | 2009 | 4 |
| INFLECTRA | CELLTRION INC | 2016 | 4 |
| SIMPONI ARIA | Johnson & Johnson | 2013 | 4 |
| RENFLEXIS | SAMSUNG BIOEPIS CO LTD | 2017 | 4 |
| AVSOLA | Amgen | 2019 | 4 |
| ZYMFENTRA | CELLTRION INC | 2023 | 2 |
| POMALIDOMIDE | HETERO LABS LTD V | 2020 | - |
TNF Drug Modality Landscape
Modalities
Routes of Administration
TNF requires biologic approaches (biologic (other)), likely due to its structure or location.
Consider exploring small molecule approaches to differentiate from existing biologic therapies.
📈 Modality Evolution
Antibodies pioneered TNF targeting (1998), with other biologics entering more recently (2008).
TNF Clinical Trials 668 trials
Phase 1-4 trials started in 2008 or later that test an FDA-approved drug acting on TNF. Source: ClinicalTrials.gov. How we count
Completion by Phase
| Phase | Total | Completed | Stopped | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 102 | 75 | 13 | 14 | 85% |
| Phase 2 | 129 | 66 | 30 | 33 | 69% |
| Phase 3 | 242 | 201 | 23 | 18 | 90% |
| Phase 4 | 195 | 124 | 31 | 40 | 80% |
Top Sponsors
By Modality
Top Conditions
Phase 3 Readout Calendar Pro
1 Phase 3 trial testing approved TNF drugs across all sponsors.
Coverage: trials whose intervention is an approved drug targeting TNF. Pre-approval candidates with development codes (e.g. AZD0901, MK-7240) are not yet linked. Anchored on CT.gov primary completion date.
TNF Drug Approval Timeline (1998 - 2024)
TNF has a long approval history spanning 27 years, with the first drug approved in 1998 and the most recent in 2024.
The continued approval of new TNF inhibitors suggests sustained market demand.
Pro Intelligence Preview
Deep insights for drug target analysis
Competitive Landscape
- • 15 companies competing
- • Market share by company
Full Drug Portfolio
- • All 21 approved drugs
- • Approval dates & indications
Genetic Validation
- • Full genetic evidence table
- • Effect sizes & directions
Approval Timeline
- • Full 21-drug timeline
- • First-of-modality markers
Clinical Trials Analysis
- • Sponsors: 272 (90 companies)
- • Completion rates by condition
Full summary • All drugs • Genetic evidence • Trials • Timeline
How We Count Trials
- Trials: phase 1-4 interventional trials on ClinicalTrials.gov that started in 2008 or later and test an FDA-approved drug acting on TNF. A trial counts if an approved drug acting on TNF is in any arm, including as a comparator, and a trial that tests two such drugs counts once. Trials that test only unapproved drugs are not counted. A trial listed as phase 1/2 counts as phase 1, and phase 2/3 as phase 2.
- Active: recruiting, not yet recruiting, enrolling by invitation, or active and no longer recruiting.
- Completion rate: of the trials that have ended, the share marked Completed rather than Terminated or Withdrawn. Completed means the trial ended as planned; it does not mean the drug worked. Suspended trials are not counted as ended.
- Stopped: terminated or withdrawn. Trials stop for many reasons, including slow enrolment and business decisions, not only safety or efficacy.
- Sponsors: the lead sponsor of each trial. Companies are the sponsors ClinicalTrials.gov classes as industry; the rest are universities, hospitals, cooperative groups, government bodies and individuals.