Last reviewed 2026-04-23 · How we verify

EU-approved Cosentyx

Celltrion · Phase 3 active Biologic

EU-approved Cosentyx is a IL-17A inhibitor (monoclonal antibody) Biologic drug developed by Celltrion. It is currently in Phase 3 development for Moderate to severe plaque psoriasis, Psoriatic arthritis, Ankylosing spondylitis. Also known as: secukinumab injection.

Cosentyx is a monoclonal antibody that blocks interleukin-17A (IL-17A), a key inflammatory cytokine involved in immune-mediated skin and joint diseases.

Cosentyx is a monoclonal antibody that blocks interleukin-17A (IL-17A), a key inflammatory cytokine involved in immune-mediated skin and joint diseases. Used for Moderate to severe plaque psoriasis, Psoriatic arthritis, Ankylosing spondylitis.

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	EU-approved Cosentyx
Also known as	secukinumab injection
Sponsor	Celltrion
Drug class	IL-17A inhibitor (monoclonal antibody)
Target	IL-17A
Modality	Biologic
Therapeutic area	Immunology / Dermatology / Rheumatology
Phase	Phase 3

Mechanism of action

IL-17A is a pro-inflammatory cytokine produced by T cells that drives inflammation in psoriasis, psoriatic arthritis, and ankylosing spondylitis. By selectively binding and neutralizing IL-17A, Cosentyx reduces the inflammatory cascade and immune cell recruitment to affected tissues, thereby reducing disease symptoms and progression.

Approved indications

Moderate to severe plaque psoriasis
Psoriatic arthritis
Ankylosing spondylitis
Non-radiographic axial spondyloarthritis

Common side effects

Nasopharyngitis
Upper respiratory tract infection
Candida infection (oral/esophageal)
Injection site reactions
Diarrhea

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:

EU-approved Cosentyx CI brief — competitive landscape report
EU-approved Cosentyx updates RSS · CI watch RSS
Celltrion portfolio CI

Frequently asked questions about EU-approved Cosentyx

What is EU-approved Cosentyx?

EU-approved Cosentyx is a IL-17A inhibitor (monoclonal antibody) drug developed by Celltrion, indicated for Moderate to severe plaque psoriasis, Psoriatic arthritis, Ankylosing spondylitis.

How does EU-approved Cosentyx work?

Cosentyx is a monoclonal antibody that blocks interleukin-17A (IL-17A), a key inflammatory cytokine involved in immune-mediated skin and joint diseases.

What is EU-approved Cosentyx used for?

EU-approved Cosentyx is indicated for Moderate to severe plaque psoriasis, Psoriatic arthritis, Ankylosing spondylitis, Non-radiographic axial spondyloarthritis.

Who makes EU-approved Cosentyx?

EU-approved Cosentyx is developed by Celltrion (see full Celltrion pipeline at /company/celltrion).

Is EU-approved Cosentyx also known as anything else?

EU-approved Cosentyx is also known as secukinumab injection.

What drug class is EU-approved Cosentyx in?

EU-approved Cosentyx belongs to the IL-17A inhibitor (monoclonal antibody) class. See all IL-17A inhibitor (monoclonal antibody) drugs at /class/il-17a-inhibitor-monoclonal-antibody.

What development phase is EU-approved Cosentyx in?

EU-approved Cosentyx is in Phase 3.

What are the side effects of EU-approved Cosentyx?

Common side effects of EU-approved Cosentyx include Nasopharyngitis, Upper respiratory tract infection, Candida infection (oral/esophageal), Injection site reactions, Diarrhea.

What does EU-approved Cosentyx target?

EU-approved Cosentyx targets IL-17A and is a IL-17A inhibitor (monoclonal antibody).

Drug class: All IL-17A inhibitor (monoclonal antibody) drugs
Target: All drugs targeting IL-17A
Manufacturer: Celltrion — full pipeline
Therapeutic area: All drugs in Immunology / Dermatology / Rheumatology
Indication: Drugs for Moderate to severe plaque psoriasis
Indication: Drugs for Psoriatic arthritis
Indication: Drugs for Ankylosing spondylitis
Also known as: secukinumab injection

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing