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EU-approved RoActemra — Competitive Intelligence Brief
phase 3
IL-6 receptor antagonist (monoclonal antibody)
IL-6R (Interleukin-6 receptor)
Immunology
Small molecule
Live · refreshed every 30 min
Target snapshot
EU-approved RoActemra (EU-approved RoActemra) — Fresenius Kabi SwissBioSim GmbH. RoActemra (tocilizumab) is a humanized monoclonal antibody that blocks the interleukin-6 (IL-6) receptor, reducing inflammatory signaling in immune-mediated diseases.
Comparator set (4 drugs)
| Drug | Generic | Sponsor | Phase | Class | Target | Approval / PDUFA |
|---|---|---|---|---|---|---|
| EU-approved RoActemra TARGET | EU-approved RoActemra | Fresenius Kabi SwissBioSim GmbH | phase 3 | IL-6 receptor antagonist (monoclonal antibody) | IL-6R (Interleukin-6 receptor) | |
| tocilizumab [RoActemra/Actemra] | tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | marketed | IL-6 receptor antagonist (monoclonal antibody) | IL-6 receptor (IL-6R) | |
| Tocilizumab(400mg) | Tocilizumab(400mg) | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | marketed | IL-6 receptor antagonist (monoclonal antibody) | IL-6 receptor (IL-6R) | |
| CT-P47 PFS (tocilizumab) | CT-P47 PFS (tocilizumab) | Celltrion | phase 3 | IL-6 receptor antagonist (monoclonal antibody) | IL-6 receptor (IL-6R) | |
| Actemra +MTX | Actemra +MTX | Zhejiang Hisun Pharmaceutical Co. Ltd. | phase 3 | IL-6 receptor antagonist (monoclonal antibody) | IL-6 receptor (IL-6R) |
Recent regulatory actions (last 90 days)
Upcoming PDUFA dates (next 180 days)
Patent timeline (forward window)
Sponsor landscape (IL-6 receptor antagonist (monoclonal antibody) class)
- Celltrion · 1 drug in this class
- Fresenius Kabi SwissBioSim GmbH · 1 drug in this class
- Hoffmann-La Roche · 1 drug in this class
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · 1 drug in this class
- Zhejiang Hisun Pharmaceutical Co. Ltd. · 1 drug in this class
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Cite this brief
Drug Landscape (2026). EU-approved RoActemra — Competitive Intelligence Brief. https://druglandscape.com/ci/eu-approved-roactemra. Accessed 2026-06-10.
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