Fact Source: Financial Supervisory Service DART
💡 3-Second Summary
Celltrion has obtained final marketing approval from the US Food and Drug Administration (FDA) for ‘Eydenzelt’ (CT-P42, ingredient: aflibercept), a biosimilar to Eylea, covering all primary indications including wet age-related macular degeneration.
📊 [Key Disclosure Details & Financial Summary]
- Disclosure Title: Final US FDA Approval for Eydenzelt (CT-P42, Eylea Biosimilar)
- Product Name: Eydenzelt (CT-P42, Eylea Biosimilar / Active Ingredient: Aflibercept)
- Regulatory Authority: US Food and Drug Administration (FDA)
- Filing & Approval Dates:
- BLA Application Date: June 29, 2023 (US Local Time)
- Final FDA Approval Date: October 2, 2025 (US Local Time)
- Fact Confirmation Date (Receipt of Official Notice): October 3, 2025
- Approved Target Indications:
- Neovascular (Wet) Age-Related Macular Degeneration (Wet-AMD)
- Macular Edema Following Retinal Vein Occlusion (RVO)
- Diabetic Macular Edema (DME)
- Diabetic Retinopathy (DR)
- Future Plans & Expected Impact:
- Celltrion plans to market and distribute Eydenzelt (CT-P42) nationwide in the US through its local US subsidiary
- Expands treatment options for patients with major ophthalmic disorders
📝 Editor’s Comment (Key Follow-up Checkpoint)
📌 Verification of Commercial Launch Schedule and US Market Penetration Progress
This disclosure confirms that Celltrion’s ophthalmic biosimilar Eydenzelt has secured final approval from the US FDA. Following regulatory approval, it is key to monitor the commercial launch timeline and marketing roll-out executed by Celltrion’s local US subsidiary. Tracking post-approval launch milestones confirms the operational transition into commercial revenue generation. Commercial execution progress and sales metrics can be verified through upcoming periodic filings (Quarterly, Half-Yearly, or Annual Business Reports) and corporate IR updates.
📢 Disclaimer & Source Information
Source: This content was newly generated and structured based on official data submitted to the Data Analysis, Retrieval and Transfer System (DART) of the Financial Supervisory Service.
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