Fact Source: Financial Supervisory Service DART
💡 3-Second Summary
Celltrion announced that it has submitted an application for a global Phase 3 clinical trial plan to the U.S. Food and Drug Administration (FDA) to evaluate the efficacy and safety of CT-P55 compared with Cosentyx in patients with plaque psoriasis.
📊 [Key Disclosure Details & Financial Highlights]
- Overview
- Title: Application for Phase 3 Clinical Trial Plan for CT-P55 (Cosentyx Biosimilar) in the U.S.
- Application Date: June 28, 2024 (Local Time)
- Regulatory Authority: U.S. Food and Drug Administration (FDA)
- Board Resolution or Fact Confirmation Date: June 28, 2024 (Date of submitting the clinical trial application to the U.S. FDA)
- Clinical Trial Details
- Trial Phase: Global Phase 3 Clinical Trial
- Indication: Plaque Psoriasis
- Clinical Trial Registration Number: EU CT number 2024-513348-27-00
- Objective: To compare efficacy and safety between CT-P55 and Cosentyx to demonstrate biosimilarity
- Number of Subjects: 375 patients
- Trial Duration: 56 weeks
- Study Design: Randomized, active-controlled, double-blind, Phase 3 clinical trial
- Future Plans & Important Notes
- Celltrion aims to demonstrate biosimilarity to the reference drug Cosentyx through efficacy and safety outcomes in this Phase 3 trial.
- Statistically, the probability of a clinical-stage drug candidate receiving final market authorization is known to be around 10%, and commercialization plans may be modified or abandoned depending on trial outcomes.
📝 Editor’s Comment (Key Follow-up Checkpoint)
📌 Verification of Approval Status of Clinical Trial Plan by the U.S. FDA
This disclosure reports the initial application stage for Phase 3 clinical trial approval in the U.S. Tracking whether final approval of the clinical trial plan is granted by regulatory authorities after review is important for determining the actual initiation of patient dosing and trial execution. Detailed progress can be verified in subsequent regulatory disclosures and upcoming periodic reports (Quarterly, Half-Yearly, or Annual Reports).
📢 Disclaimer & Source Notice
Source: This content has been newly structured and created based on official submission data from the Financial Supervisory Service’s Data Analysis, Retrieval and Transfer System (DART).
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