Fact Source: Financial Supervisory Service DART
💡 3-Second Summary
Celltrion has submitted a Marketing Authorization Application to the European Medicines Agency (EMA) and the European Commission (EC) for CT-P55, a biosimilar to Cosentyx (a treatment for autoimmune diseases). Based on the clinical data obtained, the company is seeking approval for all full adult and pediatric indications held by the reference product in Europe.
📊 [Summary of Key Disclosure Content & Major Figures]
- Application Date: July 24, 2026 (Local Time)
- Regulatory Authority: European Medicines Agency (EMA) / European Commission (EC)
- Product Name: Cosentyx Biosimilar CT-P55 (Ingredient: Secukinumab)
[Target Indications]
- Adult: Plaque psoriasis, Hidradenitis suppurativa, Psoriatic arthritis, Axial spondyloarthritis (Ankylosing spondylitis, Non-radiographic axial spondyloarthritis)
- Pediatric: Plaque psoriasis, Juvenile idiopathic arthritis (Enthesitis-Related Arthritis, Juvenile psoriatic arthritis)
[Clinical Trial Details & Key Results]
- Approval Date & Authority: December 14, 2023 / Pharmaceuticals and Medical Devices Agency (PMDA), Japan
- Registration Number: ClinicalTrials.gov Identifier: NCT07054970
- Subject Count: 172 healthy adult males (Phase 1)
- Pharmacokinetics (PK): The 90% confidence intervals for primary endpoints (AUC0-inf and Cmax) fell within the predefined equivalence margins, demonstrating pharmacokinetic equivalence to Cosentyx.
- Safety: Treatment-emergent adverse events (TEAE) occurred in 65.5% of subjects, showing comparable rates to the control group with most being mild or moderate. (One treatment-emergent serious adverse event was reported in the Cosentyx group.)
- Immunogenicity: Incidence of ADA/NAb was low and similar across study groups, showing no clinically significant impact on safety.
[Related Prior Filings]
- 2024-10-14: Application for Phase 3 Clinical Trial Plan (Part 1 & 2) of CT-P55 (Cosentyx Biosimilar) in Europe
- 2025-02-18: Approval of Phase 3 Clinical Trial Plan (Part 1 & 2) of CT-P55 (Cosentyx Biosimilar) in Europe
- 2025-10-27: Application for Phase 3 Clinical Trial Protocol Amendment (Part 1 & 2) of CT-P55 (Cosentyx Biosimilar) in Europe
- 2026-02-10: Approval of Phase 3 Clinical Trial Protocol Amendment (Part 1 & 2) of CT-P55 (Cosentyx Biosimilar) in Europe
📝 Editor’s Comment (Key Follow-up Checkpoint)
📌 European EMA/EC Acceptance of Filing and Final Review Decision
This disclosure pertains to the submission of a Marketing Authorization Application to the European EMA and EC for CT-P55 based on the clinical data obtained. Verifying whether regulatory authorities formally accept the application for validation and tracking the subsequent review decision is essential for determining whether the biosimilar can successfully move toward commercialization in Europe. Relevant updates can be verified in future regulatory disclosures, annual business reports, or quarterly and half-yearly reports.
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