Last reviewed 2026-06-02 · How we verify

Actemra(EU-licensed)

Bio-Thera Solutions · Phase 3 active Small molecule ✓ Verified Jun 2026

Actemra(EU-licensed) is a IL-6 receptor antagonist Small molecule drug developed by Bio-Thera Solutions. It is currently in Phase 3 development for Rheumatoid arthritis, Giant cell arteritis, Polyarticular juvenile idiopathic arthritis.

Actemra (tocilizumab) is an IL-6 receptor antagonist that blocks interleukin-6 signaling to reduce inflammatory responses.

Actemra (EU-licensed) is used to treat Rheumatoid Arthritis. It is administered via injection, as seen in clinical trials such as NCT03606876, which compared its pharmacokinetics to another version, BAT1806.

Likelihood of approval

59.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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.

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	Actemra(EU-licensed)
Sponsor	Bio-Thera Solutions
Drug class	IL-6 receptor antagonist
Target	IL-6R (Interleukin-6 receptor)
Modality	Small molecule
Therapeutic area	Immunology
Phase	Phase 3

Mechanism of action

Tocilizumab binds to both soluble and membrane-bound IL-6 receptors, inhibiting IL-6-mediated signal transduction. This suppresses the production of inflammatory cytokines and acute phase reactants, reducing systemic inflammation in autoimmune and inflammatory conditions.

Approved indications

Rheumatoid arthritis
Giant cell arteritis
Polyarticular juvenile idiopathic arthritis
Systemic sclerosis-associated interstitial lung disease

Common side effects

Infection (including serious infections)
Elevated liver enzymes
Neutropenia
Hyperlipidemia
Gastrointestinal perforation

Key clinical trials

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:

Actemra(EU-licensed) CI brief — competitive landscape report
Actemra(EU-licensed) updates RSS · CI watch RSS
Bio-Thera Solutions portfolio CI

Frequently asked questions about Actemra(EU-licensed)

What is Actemra(EU-licensed)?

Actemra(EU-licensed) is a IL-6 receptor antagonist drug developed by Bio-Thera Solutions, indicated for Rheumatoid arthritis, Giant cell arteritis, Polyarticular juvenile idiopathic arthritis.

How does Actemra(EU-licensed) work?

Actemra (tocilizumab) is an IL-6 receptor antagonist that blocks interleukin-6 signaling to reduce inflammatory responses.

What is Actemra(EU-licensed) used for?

Actemra(EU-licensed) is indicated for Rheumatoid arthritis, Giant cell arteritis, Polyarticular juvenile idiopathic arthritis, Systemic sclerosis-associated interstitial lung disease.

Who makes Actemra(EU-licensed)?

Actemra(EU-licensed) is developed by Bio-Thera Solutions (see full Bio-Thera Solutions pipeline at /company/bio-thera-solutions).

What drug class is Actemra(EU-licensed) in?

Actemra(EU-licensed) belongs to the IL-6 receptor antagonist class. See all IL-6 receptor antagonist drugs at /class/il-6-receptor-antagonist.

What development phase is Actemra(EU-licensed) in?

Actemra(EU-licensed) is in Phase 3.

What are the side effects of Actemra(EU-licensed)?

Common side effects of Actemra(EU-licensed) include Infection (including serious infections), Elevated liver enzymes, Neutropenia, Hyperlipidemia, Gastrointestinal perforation.

What does Actemra(EU-licensed) target?

Actemra(EU-licensed) targets IL-6R (Interleukin-6 receptor) and is a IL-6 receptor antagonist.

Drug class: All IL-6 receptor antagonist drugs
Target: All drugs targeting IL-6R (Interleukin-6 receptor)
Manufacturer: Bio-Thera Solutions — 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