Alteogen Receives Korean Approval for Aflibercept Biosimilar, Targeting Growing Retinal Disease Market
Key Insights
Alteogen secured Korean regulatory approval for Eyenefy Injection (search) (ALT-L9), a biosimilar of Bayer (search) and Regeneron's blockbuster ophthalmology drug Eylea (aflibercept).
The approval covers all indications of the original drug including wet age-related macular degeneration (search), diabetic macular edema (search), and retinal vein occlusion (search)-related visual impairment.
The biosimilar demonstrated therapeutic equivalence and safety to Eylea in global phase 3 clinical trials conducted across 12 countries including Europe, Korea, and Japan.
Alteogen announced on May 15 that it has received domestic product approval from Korea's Ministry of Food and Drug Safety for Eyenefy Injection (search) (ALT-L9), a biosimilar of the blockbuster ophthalmology drug Eylea (aflibercept). The approval positions the company to compete in Korea's rapidly expanding retinal disease treatment market, where patient numbers are increasing due to population aging.
Comprehensive Indication Coverage
The Korean approval encompasses all indications held by the original drug, including wet age-related macular degeneration (search), visual impairment due to macular edema secondary to retinal vein occlusion (search), diabetic macular edema (search), and choroidal neovascularization (search) secondary to pathologic myopia (search). Alteogen filed the marketing approval application in September 2025 and received clearance in approximately eight months.
ALT-L9 previously secured approval in Europe under the product name Eyluxvi (search) in 2025, demonstrating Alteogen's global regulatory capabilities. The Korean approval follows successful completion of global phase 3 clinical trials conducted by subsidiary Alteogen Biologics (search) across 12 countries, including Europe, Korea, and Japan.
Clinical Trial Results Support Approval
In the pivotal trials, ALT-L9 demonstrated therapeutic equivalence and safety compared to Eylea, the original drug developed by Bayer (search) and Regeneron. Eylea is widely recognized as a leading blockbuster therapy in the global ophthalmology market for treating major retinal diseases.
"Eyenefy Injection (search) was developed based on Alteogen's accumulated expertise in protein drug development and formulation research, and our subsidiary Alteogen Biologics (search) led the global clinical development and regulatory procedures," said Tae-yeon Jeon, CEO of Alteogen. "Securing domestic product approval following European approval demonstrates Alteogen's capabilities in global clinical development and regulatory compliance."
Market Impact and Future Pipeline
The biosimilar launch is expected to intensify competition in the retinal disease treatment market. An Alteogen official noted that the approval could provide "import substitution effects and expanded patient access in the ophthalmic treatment market, which has been heavily dependent on imports."
The company anticipates that if the biosimilar launch reduces drug price burdens, it could expand treatment opportunities for patients while generating savings for national health insurance finances.
Alteogen Biologics (search) is currently developing ALTS-OP01 (search), a candidate therapeutic for macular degeneration that leverages the company's global clinical and regulatory capabilities. ALTS-OP01 is designed to improve efficacy and extend dosing intervals compared to existing treatments. The company is also strengthening its pipeline for subsequent ophthalmic therapies, including filing an international patent (PCT) for high-dose formulation technology.
Jeon emphasized the company's growth trajectory, stating, "Building on our accumulated clinical development capabilities and regulatory experience, we will continue to grow as a global biopharmaceutical company with both platform technology and development expertise."