Last reviewed · How we verify
EU-approved RoActemra
EU-approved RoActemra is a IL-6 receptor antagonist (monoclonal antibody) Small molecule drug developed by Fresenius Kabi SwissBioSim GmbH. It is currently in Phase 3 development for Rheumatoid arthritis, Giant cell arteritis, Polyarticular juvenile idiopathic arthritis.
RoActemra (tocilizumab) is a humanized monoclonal antibody that blocks the interleukin-6 (IL-6) receptor, reducing inflammatory signaling in immune-mediated diseases.
RoActemra (tocilizumab) is a humanized monoclonal antibody that blocks the interleukin-6 (IL-6) receptor, reducing inflammatory signaling in immune-mediated diseases. Used for Rheumatoid arthritis, Giant cell arteritis, Polyarticular juvenile idiopathic arthritis.
-
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 | EU-approved RoActemra |
|---|---|
| Sponsor | Fresenius Kabi SwissBioSim GmbH |
| Drug class | IL-6 receptor antagonist (monoclonal antibody) |
| Target | IL-6R (Interleukin-6 receptor) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Tocilizumab binds to both membrane-bound and soluble IL-6 receptors on immune cells and endothelial cells, inhibiting IL-6-mediated signal transduction. This suppresses the production of pro-inflammatory cytokines and adhesion molecules, thereby reducing systemic inflammation and immune activation in autoimmune and inflammatory conditions.
Approved indications
- Rheumatoid arthritis
- Giant cell arteritis
- Polyarticular juvenile idiopathic arthritis
- Systemic sclerosis-associated interstitial lung disease
- COVID-19 (severe or critical)
Common side effects
- Infections (including serious infections)
- Elevated liver enzymes (ALT/AST)
- Hyperlipidemia
- Neutropenia
- Headache
- Hypertension
- Gastrointestinal perforation (rare)
Key clinical trials
- An Observational Study on RoActemra/Actemra (Tocilizumab) in Clinical Practice in Patients With Rheumatoid Arthritis (TRUST)
- A Study to Compare Efficacy and Safety of CT-P47 and RoActemra in Patients With Rheumatoid Arthritis (PHASE3)
- MSB11456 in Participants With Moderately to Severely Active Rheumatoid Arthritis (PHASE3)
- A Study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects (PHASE1)
- Pharmacokinetics/Pharmacodynamics (PK/PD) Equivalence Study of MSB11456 (PHASE1)
- Phase I, Pharmacokinetic, Safety and Tolerability Study in Healthy Volunteers (PHASE1)
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:
- EU-approved RoActemra CI brief — competitive landscape report
- EU-approved RoActemra updates RSS · CI watch RSS
- Fresenius Kabi SwissBioSim GmbH portfolio CI
Frequently asked questions about EU-approved RoActemra
What is EU-approved RoActemra?
How does EU-approved RoActemra work?
What is EU-approved RoActemra used for?
Who makes EU-approved RoActemra?
What drug class is EU-approved RoActemra in?
What development phase is EU-approved RoActemra in?
What are the side effects of EU-approved RoActemra?
What does EU-approved RoActemra target?
Related
- Drug class: All IL-6 receptor antagonist (monoclonal antibody) drugs
- Target: All drugs targeting IL-6R (Interleukin-6 receptor)
- Manufacturer: Fresenius Kabi SwissBioSim GmbH — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Rheumatoid arthritis
- Indication: Drugs for Giant cell arteritis
- Indication: Drugs for Polyarticular juvenile idiopathic arthritis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing