On May 22, Alteogen Inc. (CEO Soon Jae Park), a South Korean biotechnology company developing Eylea biosimilar (ALT-L9) to treat macular degeneration, announced that it gained Investigational New Drug (IND) approval for Phase 1 clinical trial from Ministry of Food and Drug Safety in Korea.
The phase I, randomized and double-blinded trial will be conducted in one of the five major hospitals in Korea in terms of its safety, efficacy, and pharmacokinetic study in wet age-related macular degeneration patients comparing to the originator’s Eylea as a reference drug.
Eylea has been evergreened by originator to extend the patent period to maintain exclusive right additional 5 years after expiring substance patent. As a result, biosimilar launch by incoming developers using the same formulation as the originator will be delayed for five years after the substance patent expires. However, Alteogen Inc. self-developed Eylea formulation technology and had already registered the patent in Korea, the U.S. and other countries. Also, it secured a global competitiveness by registering process patents for optimization of culturing conditions of Aflibercept, an active ingredient of Eylea.
Eylea is a vascular endothelial growth factor (VEGF) inhibitor and has various indications such as wet age-related macular degeneration, diabetic macular edema, and macular edema following retinal vein occlusion. Eylea can be injected once every 2-3 months which makes superior in its convenience compared to its competing drug, Lucentis, which requires monthly injection. The global net sales of Eylea were approximately US $7B in 2018.
An official from Alteogen said, "The domestic clinical trial of Eylea Biosimilar is the first in Korea, which shows our potential as the first runner.” “We will initiate the global Phase 3 clinical trial this year to build the foundation for entry into the global market including the US, Europe, and Japan. We are already receiving many inquiries regarding the technology transfer from global pharmaceutical companies around the world,” he added.