Fact Source: Financial Supervisory Service DART
💡 3-Second Summary
Celltrion announced that it has received final marketing authorization from the European Commission (EC) for Steqeyma (CT-P43), a biosimilar to Stelara, covering 30 European countries for indications including plaque psoriasis and Crohn’s disease.
📊 [Key Disclosure Details & Financial Highlights]
- Overview
- Title: Final Marketing Authorization Granted by European Commission (EC) for Steqeyma (CT-P43, Stelara Biosimilar)
- Product Name: Steqeyma (CT-P43, Active Ingredient: Ustekinumab)
- Regulatory Authority: European Commission (EC)
- Fact Confirmation Date: August 24, 2024 (Date of confirming EC final marketing authorization)
- Key Regulatory Timeline
- Application Date: May 25, 2023 (Local Time)
- CHMP Positive Opinion Date: June 27, 2024 (Local Time)
- EC Final Approval Date: August 23, 2024 (Local Time)
- Approved Indications
- Plaque psoriasis
- Paediatric plaque psoriasis
- Psoriatic arthritis
- Crohn’s disease
- Future Plans & Expected Effects
- Celltrion plans to sell Steqeyma across 30 European countries through its local subsidiaries in Europe.
- Aims to advance commercialization in the European market by offering treatment options for key approved indications.
📝 Editor’s Comment (Key Follow-up Checkpoint)
📌 Verification of Local Launch and Revenue Contribution via European Subsidiaries
This disclosure confirms that final marketing authorization has been obtained from the European Commission (EC), completing the legal foundation for local commercialization. Tracking whether the product is officially launched in individual countries through local sales subsidiaries and how it reflects in actual top-line revenue is important for evaluating the growth of the company’s biosimilar business. Detailed updates can be verified in 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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