Alteogen said Wednesday that it has registered a patent on quality improvement and mass production of cultivation condition method for the production of Eylea biosimilar fusion protein.
This patent is a method of producing Aflibercept, a fusion protein of the soluble extracellular of the vascular endothelial growth factor (VEGF) receptor domain and the immunoglobulin G (IgG) fragment crystallizable (Fc) domain.
Eylea is a VEGF inhibitor and has various indications such as wet, age-related macular degeneration, retinal vein occlusion macular edema, and diabetic retinopathy associated with diabetic macular edema. This drug is more convenient compared to Lusentis, a competition drug, as patients can inject the treatment once every 2-3 months compared to once every month.
According to Pharma Compass, a biopharmaceutical information site, Eylea is a blockbuster drug that ranked third in sales with $8.26 billion in 2017, a 14.6 percent increase from the previous year.
However, due to restrictions on formulation patents, it is still a difficult product to develop.
The company managed to improve productivity and quality of the fusion protein essential for the production of Eylea biosimilars by optimizing the culturing conditions of the cells producing the fusion protein that have IgG Fc domain as well as the technology for mass-producing and supplying such fusion proteins.
“The company’s patent is a key ingredient that can improve both productivity and similarity through temperature control in the incubation process of Eylea biosimilars,” a company official said. “It can also block the entry of competitors who want to develop Eylea biosimilars.”
This patent is likely to strengthen the competitiveness of Alteogen’s Eyelia biosimilars, helping the product become a global first mover, he added.