Alteogen Secures Domestic Approval for Aflibercept Biosimilar ‘Eygenpiju’ in South Korea, Accelerating Global Reach

Daum South Korea

Overview

South Korean biopharmaceutical company Alteogen announced domestic market approval from the Ministry of Food and Drug Safety (MFDS) for ‘Eygenpiju’ (ALT-L9), its aflibercept biosimilar. This approval follows European market authorization under the brand ‘Eyluxvi’ last year, expanding its global footprint. The domestic approval is based on global Phase 3 trials conducted across 12 countries, including Europe, Korea, and Japan, which successfully demonstrated therapeutic equivalence and safety to the originator drug, Eylea. Alteogen plans its domestic launch while also advancing ‘ALTS-OP01’, a novel macular degeneration candidate, and high-dose formulation technologies, including an international patent filing.

In Depth

Background

Ophthalmic diseases, particularly age-related macular degeneration and diabetic macular edema, are primarily treated with anti-VEGF (vascular endothelial growth factor) agents, which play a central role in inhibiting neovascularization. While highly effective, these drugs often impose a significant economic burden on patients and healthcare systems. Consequently, there is a global increase in demand for biosimilars, which are expected to offer comparable efficacy and safety to originator biologics at more accessible prices. South Korea’s Alteogen has focused its efforts on developing complex biosimilars to address this growing market need.

Key Findings / Results

On May 15, 2026, South Korean biopharmaceutical company Alteogen announced that it had received domestic marketing authorization from the Ministry of Food and Drug Safety (MFDS) for ‘Eygenpiju’ (ALT-L9), its biosimilar to aflibercept. This approval is a significant milestone in Alteogen’s global expansion strategy, following its market authorization in Europe last year under the brand name ‘Eyluxvi’. The domestic approval is underpinned by results from global Phase 3 clinical trials conducted by Alteogen Biologics, a subsidiary, across 12 countries, including Europe, South Korea, and Japan. These trials successfully demonstrated therapeutic equivalence and safety when compared to the originator drug, Eylea (aflibercept).

Following this new approval, Alteogen plans to proceed with the domestic launch of Eygenpiju in South Korea. Furthermore, the company is actively advancing the development of ‘ALTS-OP01’, a novel candidate for macular degeneration treatment that aims to improve efficacy and extend the dosing interval compared to existing therapies. In connection with this, Alteogen has also filed an international patent (PCT) for a high-dose formulation technology, indicating its focus on innovation in delivery and formulation technologies.

Technical Significance & Outlook

The domestic approval of Alteogen’s Eygenpiju holds significant implications for South Korean patients, providing a cost-effective alternative to aflibercept and enhancing healthcare accessibility. With approvals now in both Europe and its home market, Alteogen’s global competitiveness and presence are further strengthened. This demonstrates that South Korean biopharmaceutical companies possess world-class clinical development capabilities and regulatory expertise in the complex field of biosimilar development. The development of the novel macular degeneration treatment candidate ALTS-OP01 and investments in high-dose formulation technology suggest that Alteogen is committed not only to biosimilars but also to innovative drug development. Extending the dosing interval, in particular, has the potential to significantly improve patient convenience and adherence, addressing a crucial unmet medical need. Future attention will be on the market introduction of Eygenpiju and the clinical development progress of its novel pipeline assets.