CT-P55 (Cosentyx Biosimilar) US Phase 3 Trial Plan Amendment Approved by FDA
- Celltrion's CT-P55 (Cosentyx biosimilar) US Phase 3 clinical trial plan amendment has been approved by the FDA (approval date: 2026-05-12, submission date: 2026-03-12).
- The trial is a randomized, double-blind, active-controlled, Phase 3 study in 153 patients with moderate-to-severe plaque psoriasis over 56 weeks.
- Objective: compare efficacy and safety of CT-P55 vs. original Cosentyx to demonstrate biosimilarity.
- Disclosure includes investment risk warning: approximately 10% probability of final drug approval, and possibility of commercial plan changes.
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KOSPI Filing Information
- Filing: Major Management Matters Related to Investment Decision (CTP55 (Cosentics Biosimilar) Approval of Change Application for US Phase 3 Clinical Trial Plan)
- Company: Celltrion (068270)
- Submission: Celltrion, Inc.
- Receipt: 05-12-2026
- Under KRX KOSPI Market Division