Fact Source: Financial Supervisory Service DART
💡 3-Second Summary
Celltrion announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorization for CT-P43, a biosimilar to Stelara, across 30 European countries.
📊 [Key Disclosure Details & Financial Highlights]
- Overview
- Title: CHMP Positive Opinion Granted for CT-P43 (Stelara Biosimilar) by EMA
- Product Name: CT-P43 (Stelara Biosimilar, Active Ingredient: Ustekinumab)
- Regulatory Authority: Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA)
- Fact Confirmation Date: June 28, 2024 (Date of confirming CHMP positive opinion)
- Key Regulatory Timeline
- Application Date: May 25, 2023 (Local Time)
- CHMP Positive Opinion Date: June 27, 2024 (Local Time)
- Approved Indications & Recommendation Scope
- Indications: Plaque psoriasis, Paediatric plaque psoriasis, Psoriatic arthritis, Crohn’s disease
- Recommendation Scope: Marketing authorization recommendation for 30 European countries
- Future Plans & Expected Effects
- Following the CHMP positive opinion, Celltrion expects to receive final marketing authorization from the European Commission (EC) in the near future.
- Aims to provide expanded treatment options for major indications across Europe.
📝 Editor’s Comment (Key Follow-up Checkpoint)
📌 Verification of Final Marketing Authorization Grant by the European Commission (EC)
This disclosure confirms a positive opinion from the EMA’s CHMP as a key step toward commercialization in Europe. Tracking whether this progresses to final marketing authorization from the European Commission (EC) is important for confirming the official legal clearance to market the biosimilar across European countries. Detailed updates 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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