Celltrion Submits EU Marketing Authorization Application for CT-P55 Cosentyx Biosimilar
Celltrion has submitted a marketing authorization application for its CT-P55 biosimilar of Cosentyx to the European Medicines Agency and the European Commission.
The application covers multiple indications including plaque psoriasis, hidradenitis suppurativa, psoriatic arthritis, and axial spondyloarthritis, supported by a Phase 1 trial demonstrating pharmacokinetic equivalence and comparable safety and immunogenicity.
This disclosure does not involve any capital changes or immediate financial impact; it is a regulatory milestone update.
[AI Summary]Celltrion's EU submission for CT-P55 is positive for pipeline expansion but has no immediate financial impact. Regulatory approval could contribute to mid-to-long-term revenue, but investors should account for approval uncertainties.
KOSPI Filing Information
Major Management Matters Related to Investment Decision (Application for European Marketing Authorization for CTP55 (Cosentics Biosimilar))