Alteogen announced on the 28th that it has obtained a positive opinion for the product license of the Eyluxvi biosimilar, jointly developed with Alteogen Biologics, from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA). The project is named ALT-L9.
Typically, the official product license is decided two to three months after the positive opinion from CHMP.
Alteogen's subsidiary Alteogen Biologics demonstrated equivalence and safety with Eylea through a Phase 3 clinical trial conducted in 12 countries, including Europe, Korea, and Japan, from June 2022 to February 2024.
Eylea, a treatment for ophthalmic diseases such as wet age-related macular degeneration and diabetic macular edema, had annual sales reaching 13 trillion won as of last year.
Park Sun-jae, CEO of Alteogen, said, "Alteogen holds various patents regarding formulations and manufacturing processes for the Eylea biosimilar, which differentiates it from competing products, and we will provide new treatment options that are accessible to patients suffering from eye diseases."