Alteogen said Friday that it has filed an investigational new drug application for ALT-L9, an Eylea biosimilar, to the Ministry of Food and Drug Safety.
Eylea (Ingredient: aflibercept), developed by Regeneron, is a vascular endothelial growth factor inhibitor used to treat wet, advanced age-related macular degeneration, among other conditions. The treatment is a blockbuster product that recorded $8.26 billion in sales in 2017, according to Pharma Compass.
The Korean company plans to conduct a randomized, double-blinded and actively controlled clinical study, which will evaluate the safety, efficacy and pharmacokinetic of ALT-L9 in patients with neovascular age-related macular degeneration. Alteogen plans to use the original Eylea as a comparison drug and will conduct the research at five local hospitals.
The trial comes after the company confirmed that the company's biosimilar is more stable than the original Eylea through a thermal stability comparison tests during the formulation process.
Alteogen has independently developed Eylea's formulation and has registered related patents in Korea and the U.S. to secure competitiveness against other biosimilar developers. The company said it has also gained a global competitive edge by registering production patents for optimizing culture conditions of Aflibercept, a component of Eylea, blocking the entry of other competitors to develop Eylea biosimilars.
“The clinical trial of the company’s Eylea biosimilar is proceeding faster than our competitors, so it is highly likely to become the first mover in the field,” a company official said. “We plan to establish a foundation for entry into the U.S., Europe, Korea, Japan, and other markets this year by launching work for the global phase 3 clinical trials.”