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.
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)