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DMARDs or Biologics
DMARDs or Biologics is a Biologic DMARD Small molecule drug developed by Pfizer. It is currently in Phase 2 development for Rheumatoid Arthritis, Psoriatic Arthritis, Polyarticular Juvenile Idiopathic Arthritis.
T-cell co-stimulation inhibitor
T-cell co-stimulation inhibitor Used for Rheumatoid Arthritis, Psoriatic Arthritis, Polyarticular Juvenile Idiopathic Arthritis.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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. -
Big-pharma sponsor
+3.0pp
Pfizer is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | DMARDs or Biologics |
|---|---|
| Sponsor | Pfizer |
| Drug class | Biologic DMARD |
| Target | IL-6R |
| Modality | Small molecule |
| Therapeutic area | Rheumatology |
| Phase | Phase 2 |
Mechanism of action
DMARDs or Biologics, such as Tocilizumab, work by inhibiting the co-stimulation of T-cells, thereby reducing inflammation and autoimmune responses.
Approved indications
- Rheumatoid Arthritis
- Psoriatic Arthritis
- Polyarticular Juvenile Idiopathic Arthritis
Common side effects
- Increased risk of infections
- Neutropenia
- Lipid elevations
Key clinical trials
- The SetPoint System Safety & Performance Post-Approval Study
- Continuation Study of Zasocitinib in Adults With Psoriatic Arthritis (PHASE3)
- A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines (PHASE3)
- Early Adalimumab Induction for Immune Checkpoint Inhibitor Associated Inflammatory Arthritis (PHASE2)
- A Study of Clinical and Immune Responses to Sequential Biologic Therapies in Psoriatic Arthritis
- Modifying PEST for Psoriatic Arthritis Screening (NA)
- Analysis of T and B Cell Repertoire Changes in Response to Orencia® (Abatacept) in Rheumatoid Arthritis
- Severe Psoriatic Arthritis - Early intervEntion to Control Disease: the SPEED Trial (PHASE4)
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:
- DMARDs or Biologics CI brief — competitive landscape report
- DMARDs or Biologics updates RSS · CI watch RSS
- Pfizer portfolio CI
Frequently asked questions about DMARDs or Biologics
What is DMARDs or Biologics?
How does DMARDs or Biologics work?
What is DMARDs or Biologics used for?
Who makes DMARDs or Biologics?
What drug class is DMARDs or Biologics in?
What development phase is DMARDs or Biologics in?
What are the side effects of DMARDs or Biologics?
What does DMARDs or Biologics target?
Related
- Drug class: All Biologic DMARD drugs
- Target: All drugs targeting IL-6R
- Manufacturer: Pfizer — full pipeline
- Therapeutic area: All drugs in Rheumatology
- Indication: Drugs for Rheumatoid Arthritis
- Indication: Drugs for Psoriatic Arthritis
- Indication: Drugs for Polyarticular Juvenile Idiopathic Arthritis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing