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US-licensed Actemra
US-licensed Actemra is a Small molecule drug developed by Fresenius Kabi SwissBioSim GmbH. It is currently in Phase 1 development.
US-licensed Actemra is an interleukin-6 inhibitor used to treat conditions such as rheumatoid arthritis. It works by inhibiting the interleukin-6 molecular target.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | US-licensed Actemra |
|---|---|
| Sponsor | Fresenius Kabi SwissBioSim GmbH |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Comparative Study to Evaluate the Pharmacokinetics of BAT1806 vs Actemra® in Healthy Subjects (PHASE1)
- Pharmacokinetics/Pharmacodynamics (PK/PD) Equivalence Study of MSB11456 (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:
- US-licensed Actemra CI brief — competitive landscape report
- US-licensed Actemra updates RSS · CI watch RSS
- Fresenius Kabi SwissBioSim GmbH portfolio CI
Frequently asked questions about US-licensed Actemra
What is US-licensed Actemra?
Who makes US-licensed Actemra?
What development phase is US-licensed Actemra in?
Related
- Manufacturer: Fresenius Kabi SwissBioSim GmbH — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing