Alteogen’s Eylea Biosimilar Clears EU Hurdle

Photo: Exterior view of Alteogen headquarters and research center.

Alteogen has cleared a major regulatory hurdle in its bid to enter the European biosimilar market.

The Korean biopharmaceutical company announced on July 28 that the Committee for Medicinal Products for Human Use (CHMP), under the European Medicines Agency (EMA), has issued a positive opinion for its Eylea (aflibercept) biosimilar ALT-L9, branded as Eyluxvi.

A CHMP positive opinion is a key step in the EU drug approval process and typically leads to European Commission (EC) authorization within two to three months.

ALT-L9 is a biosimilar of Eylea, a blockbuster anti-VEGF therapy widely used for wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). The global market for Eylea exceeded $9.5 billion (KRW 13 trillion) in 2024.

The positive recommendation is based on data from a global Phase 3 trial conducted across 12 countries, including the EU, Korea, and Japan. The study enrolled 431 patients with wAMD and demonstrated equivalent efficacy and safety compared to the reference product.

Dr. Soon Jae Park, CEO of Alteogen, stated, "ALT-L9's progress toward EU approval validates the global competitiveness of Korean biosimilars. Our portfolio of formulation and manufacturing patents also offers a strong differentiation edge in the market."

The company plans to launch commercial operations in Europe in the second half of 2025, pending final EC approval.

ALT-L9 is expected to become Alteogen's second revenue-generating biosimilar in the global market. Previously, the company licensed its trastuzumab biosimilar ALT-L2 to Qilu Pharmaceutical in China. That product received Chinese regulatory approval last year and has since been commercialized, generating royalty income for Alteogen based on net sales.

Industry analysts see ALT-L9's EU progress as a key milestone in expanding Alteogen's global biosimilar footprint.

원종혁 기자 (every83@kormedi.com)