Last reviewed · How we verify
Biological DMARDs
Biological DMARDs is a Biological DMARD Small molecule drug developed by Hoffmann-La Roche. It is currently in Phase 2 development for Rheumatoid arthritis, Psoriatic arthritis, Juvenile idiopathic arthritis.
Biological DMARDs work by targeting specific proteins involved in the immune response to reduce inflammation and slow disease progression.
Biological Disease-Modifying Antirheumatic Drugs (DMARDs) are used to treat conditions such as Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis. Filgotinib is an example of a Biological DMARD that has been studied in clinical trials for these conditions.
-
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
Hoffmann-La Roche 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 | Biological DMARDs |
|---|---|
| Sponsor | Hoffmann-La Roche |
| Drug class | Biological DMARD |
| Target | TNF-alpha, IL-6, JAK |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 2 |
Mechanism of action
Biological DMARDs, such as those targeting TNF-alpha, IL-6, or JAK, work by binding to their respective receptors, thereby inhibiting the downstream signaling pathways that lead to inflammation and tissue damage. This results in reduced joint damage and improved symptoms in patients with autoimmune diseases like rheumatoid arthritis.
Approved indications
- Rheumatoid arthritis
- Psoriatic arthritis
- Juvenile idiopathic arthritis
Common side effects
- Increased risk of infections
- Allergic reactions
- Liver enzyme 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)
- Coronavirus Anxiety in Patients Using Biologic vs Conventional DMARDs
- Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic Drug (PHASE3)
- A Study of Clinical and Immune Responses to Sequential Biologic Therapies in Psoriatic Arthritis
- Modifying PEST for Psoriatic Arthritis Screening (NA)
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:
- Biological DMARDs CI brief — competitive landscape report
- Biological DMARDs updates RSS · CI watch RSS
- Hoffmann-La Roche portfolio CI
Frequently asked questions about Biological DMARDs
What is Biological DMARDs?
How does Biological DMARDs work?
What is Biological DMARDs used for?
Who makes Biological DMARDs?
What drug class is Biological DMARDs in?
What development phase is Biological DMARDs in?
What are the side effects of Biological DMARDs?
What does Biological DMARDs target?
Related
- Drug class: All Biological DMARD drugs
- Target: All drugs targeting TNF-alpha, IL-6, JAK
- Manufacturer: Hoffmann-La Roche — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Rheumatoid arthritis
- Indication: Drugs for Psoriatic arthritis
- Indication: Drugs for Juvenile idiopathic arthritis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing