Fact Source: Financial Supervisory Service DART
💡 3-Second Summary
Celltrion has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for CT-P55, a biosimilar to Cosentyx (a treatment for autoimmune diseases). Based on the clinical data obtained, the company is seeking approval for six indications, including plaque psoriasis.
📊 [Summary of Key Disclosure Content & Major Figures]
- Application Date: July 30, 2026 (Local Time)
- Regulatory Authority: U.S. Food and Drug Administration (FDA)
- Product Name: Cosentyx Biosimilar CT-P55 (Ingredient: Secukinumab)
[Target Indications]
- Plaque psoriasis
- Psoriatic arthritis
- Ankylosing spondylitis
- Non-radiographic axial spondyloarthritis
- Enthesitis-Related Arthritis
- Hidradenitis suppurativa
[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]
- 2024-07-01: Application for Phase 3 Clinical Trial Plan of CT-P55 (Cosentyx Biosimilar) in the U.S.
- 2024-08-14: Approval of Phase 3 Clinical Trial Plan of CT-P55 (Cosentyx Biosimilar) in the U.S.
- 2026-03-12: Application for Phase 3 Clinical Trial Protocol Amendment of CT-P55 (Cosentyx Biosimilar) in the U.S.
- 2026-05-12: Approval of Phase 3 Clinical Trial Protocol Amendment of CT-P55 (Cosentyx Biosimilar) in the U.S.
📝 Editor’s Comment (Key Follow-up Checkpoint)
📌 U.S. FDA Acceptance of BLA Filing and Final Review Decision
This disclosure pertains to the submission of a Biologics License Application (BLA) to the U.S. FDA for CT-P55 based on the clinical data obtained. Verifying whether the regulatory authority formally accepts the application for filing and tracking the subsequent review decision is essential for determining whether the biosimilar can successfully move toward commercialization. Relevant updates can be verified in future regulatory disclosures, annual business reports, or quarterly and half-yearly reports.
📢 Disclaimer & Source Notice
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