Phase 1 Clinical Trial of Aflibercept (Eylea®) Biosimilar Completed by Alteogen

Alteogen recently announced that it has successfully completed a Phase 1 clinical trial for its Eylea® biosimilar, ALT-L9.  Alteogen conducted the clinical trials in South Korea, where its headquarters are located.  In the clinical trials, ALT-L9 and Eylea® were randomly assigned to 28 patients with neovascular (wet) age-related macular degeneration (wet AMD).  Alteogen reported that its clinical trial results showed similar safety and efficacy between ALT-L9 and Eylea® which will support Alteogen’s phase 3 clinical trials and may even provide a path to a shorter phase 3 trial.

Eylea® is indicated for Wet AMD, Diabetic Macular Edema (DME), and Macular Edmea following Retinal Vein Occlusion (MEfRVO).  While there are currently no approved biosimilars to Eylea®, Alteogen (ALT-L9), Mylan (MYL-1701P), Samsung Bioepis (SB15), Amgen (ABP 938), Formycon (FYB203), and Coherus Biosciences (CHS-2020) are developing such biosimilars.