TNF Inhibitors & Biosimilars
20 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.
Strategic Insights
ℹ️ How we calculate- White space opportunity in Diabetes Mellitus, Type 1 with only 5 trials.
- Emerging modalities (Antibody, Fusion protein) signal innovation opportunity.
Human 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 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 |
| YUSIMRY | COHERUS BIOSCIENCES INC | 2021 | 9 |
| YUFLYMA | CELLTRION | 2023 | 9 |
| CYLTEZO | Boehringer Ingelheim | 2017 | 9 |
| SIMLANDI | ALVOTECH USA INC | 2024 | 9 |
| HADLIMA | SAMSUNG BIOEPIS CO LTD | 2019 | 9 |
| IDACIO | Fresenius Kabi | 2022 | 8 |
| HULIO | Viatris | 2020 | 8 |
| REMICADE | Johnson & Johnson | 1998 | 8 |
| CIMZIA | UCB INC | 2008 | 7 |
| ENBREL | IMMUNEX | 1998 | 6 |
| INFLECTRA | CELLTRION INC | 2016 | 4 |
| RENFLEXIS | SAMSUNG BIOEPIS CO LTD | 2017 | 4 |
| AVSOLA | Amgen | 2019 | 4 |
| SIMPONI | Johnson & Johnson | 2009 | 4 |
| SIMPONI ARIA | Johnson & Johnson | 2013 | 4 |
| POMALIDOMIDE | HETERO LABS LTD V | 2020 | - |
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).
Clinical Trials 721 trials
Completion by Phase
| Phase | Total | Completed | Failed | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 122 | 90 | 13 | 19 | 87% |
| Phase 2 | 150 | 82 | 33 | 35 | 71% |
| Phase 3 | 259 | 210 | 23 | 25 | 90% |
| Phase 4 | 190 | 123 | 32 | 34 | 79% |
Top Sponsors
By Modality
Top Conditions
Phase 3 Readout Calendar Pro
4 Phase 3 trials 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.
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
- • 16 companies competing
- • Market share by company
Full Drug Portfolio
- • All 20 approved drugs
- • Approval dates & indications
Genetic Validation
- • Full genetic evidence table
- • Effect sizes & directions
Approval Timeline
- • Full 20-drug timeline
- • First-of-modality markers
Clinical Trials Analysis
- • Competition: High (15 sponsors)
- • White space: 4 underexplored indications
- • Success rates by condition
Full summary • All drugs • Genetic evidence • Trials • Timeline
How We Calculate These Metrics
Target Attractiveness Score
A 0-100 score based on trial activity, sponsor diversity, and completion rates. Calculated from 363 clinical trials targeting TNF.
Completion rate: Percentage of trials that reached their planned endpoint. Trials terminated early, withdrawn, or suspended are not counted—these often indicate safety issues, lack of efficacy, or strategic pivots.
- Highly Attractive (80+): High trial activity, many sponsors, strong completion rates
- Attractive (60-79): Good trial activity and validation
- Moderate (40-59): Moderate interest from sponsors
- Low (under 40): Limited trial activity or validation concerns
Strategic Insights
Auto-generated insights based on trial analytics including competition intensity, white space opportunities, modality shifts, and failure patterns. We analyze trial sponsors, phases, indications, and outcomes.
Risk Signals
- High Competition: Many sponsors competing for this target (may reduce market opportunity)
- High Failure Risk: Low trial completion rates suggest development challenges
- Low Validation: Limited trial activity or poor outcomes indicate uncertain viability
- White Space Available: Underexplored indications present opportunities