Fact Source: Financial Supervisory Service DART
💡 3-Second Summary
Celltrion announced that it has obtained final marketing authorization from the European Commission (EC) for Omlyclo (CT-P39), a biosimilar to Xolair, covering 30 European countries for all approved indications of the reference drug.
📊 [Key Disclosure Details & Financial Highlights]
- Overview
- Title: Final Marketing Authorization Granted by European Commission (EC) for Omlyclo (CT-P39, Xolair Biosimilar)
- Product Name: Omlyclo (CT-P39, Active Ingredient: Omalizumab)
- Regulatory Authority: European Commission (EC)
- Board Resolution or Fact Confirmation Date: May 23, 2024 (Date of confirming EC final approval)
- Key Regulatory Timeline
- Application Date: April 24, 2023 (Local Time)
- CHMP Positive Opinion Date: March 21, 2024 (Local Time)
- EC Final Approval Date: May 22, 2024 (Local Time)
- Approved Indications & Scope
- Indications: Allergic asthma, Chronic rhinosinusitis with nasal polyps, Chronic spontaneous urticaria
- Approval Scope: Final marketing authorization covering 30 European countries
- Future Plans & Expected Effects
- Secured final marketing authorization for all indications approved for the reference drug.
- Celltrion plans to market Omlyclo (CT-P39) across Europe through its local subsidiaries.
📝 Editor’s Comment (Key Follow-up Checkpoint)
📌 Verification of Sales Launch in Europe and Subsequent Disclosures
This disclosure confirms that final marketing authorization has been granted by the European Commission (EC), completing the legal approval required for commercialization across 30 European countries. Tracking post-approval progress, such as the actual initiation of European sales and revenue generation through local subsidiaries, is important for assessing the commercialization performance of the biosimilar pipeline. Detailed updates can be verified in subsequent 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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