Alteogen's Eylea biosimilar wins EMA panel backing

Alteogen, a Korean biotech company, said it has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for Eyluxvi, its biosimilar to Eylea (ingredient: aflibercept), jointly developed with its subsidiary Alteogen Biologics.

Eylea, originally developed by Regeneron Pharmaceuticals, is a blockbuster ophthalmology drug widely used to treat wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). The product recorded global sales of approximately 13 trillion won ($9.4 billion) in 2024, making it one of the most lucrative biologics in the field.

The CHMP’s recommendation plays a decisive role in the European Commission’s final decision to authorize a medicine. Full approval typically follows two to three months after the committee issues its positive opinion.

The EMA panels recommendation was based on results from a phase 3 clinical trial conducted across 12 countries, including Korea, Japan, and major European markets. Between June 2022 and February 2024, the company enrolled 431 wAMD patients and evaluated the efficacy and safety of ALT-L9 in comparison with reference Eylea. The trial successfully demonstrated therapeutic equivalence and safety parity between the two products.

“We are pleased to receive CHMP’s positive opinion for ALT-L9 as part of the European marketing authorization process,” Alteogen CEO Park Soon-jae said. “We hold formulation and manufacturing patents related to our Eylea biosimilar, which differentiates it from other competitors.”

The product is expected to offer a more affordable and accessible treatment option for patients suffering from debilitating retinal diseases, Park added.