South Korea’s Alteogen announced that its aflibercept biosimilar ALT-L9 had demonstrated similarity to the originator with no significant side effects in Michigan-based non-clinical trials. Aflibercept, known commercially as Eylea®, is sold by Regeneron for the treatment of wet age-related macular degeneration, which is the leading cause of blindness among the elderly. Both Eylea® and ALT-L9 were injected into monkey eyes four times every four weeks. Alteogen reported that after 13 weeks, its investigational drug was similar to the originator in efficacy and safety. Alteogen also noted that ALT-L9 has been developed with its own composition and formulation to make it more resilient to high temperatures, which Alteogen hopes will achieve a longer shelf life than the originator formulation.
Alteogen announced that it will file an Investigational New Drug application for its biosimilar candidate with FDA this year.