Alteogen Seeks Approval for Aflibercept Biosimilar ALT-L9 in Korea
核心洞察
Alteogen has applied for marketing authorization in Korea for ALT-L9, a biosimilar of aflibercept (Eylea®), marking a significant step in expanding treatment options for retinal diseases.
A Phase 3 study conducted across 12 countries demonstrated that ALT-L9 met its primary endpoint, establishing therapeutic equivalence to the reference product, Eylea®.
Alteogen's subsidiary, Altos Biologics, previously submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for ALT-L9, with potential approval expected in 2025.
Alteogen has announced its application for marketing authorization in Korea for ALT-L9, a biosimilar of aflibercept, known commercially as Eylea®. This application, submitted on September 13, 2024, follows a Phase 3 study that demonstrated therapeutic equivalence between ALT-L9 and Eylea®. The study, conducted across 12 countries, met its primary endpoint, paving the way for a potentially more accessible treatment option for patients with retinal diseases.
Phase 3 Trial Results
The Phase 3 trial was designed to evaluate the efficacy, safety, and immunogenicity of ALT-L9 compared to Eylea®. According to Alteogen, the study successfully demonstrated that ALT-L9 is therapeutically equivalent to Eylea® in treating relevant retinal conditions. Specific details regarding the patient population, dosing regimen, and statistical significance (p-values, confidence intervals) of the primary and secondary endpoints were not disclosed in the announcement but are expected to be part of the regulatory review process.
Regulatory Pathway
Prior to the submission in Korea, Alteogen's subsidiary, Altos Biologics, submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for ALT-L9 on July 1, 2024. Altos Biologics anticipates a decision from the EMA in 2025. The dual submissions in both Europe and Korea highlight Alteogen's strategic approach to bringing this aflibercept biosimilar to market globally.
Aflibercept and its Role
Aflibercept is a recombinant fusion protein acting as a VEGF (搜索) (vascular endothelial growth factor) inhibitor. It is used to treat several ophthalmic conditions, including neovascular (wet) age-related macular degeneration (搜索) (AMD), macular edema (搜索) following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (搜索) (DR). These conditions are significant causes of vision loss worldwide, creating a substantial medical need for effective and affordable treatments.
Implications of Biosimilar Approval
If approved, ALT-L9 could offer a more cost-effective alternative to Eylea®, potentially increasing patient access to this important medication. Biosimilars are designed to have the same clinical effect as their reference product but are typically priced lower, which can reduce the financial burden on healthcare systems and patients. The introduction of ALT-L9 could foster greater competition in the aflibercept market, potentially driving down prices and improving overall affordability.