Celltrion applies for approval in Europe for eye treatment biosimilar
Dae-Kyu Ahn
Nov 24, 2023 (Gmt+09:00)
South Korean biopharmaceutical company Celltrion Inc. announced on Friday that it applied for approval from the European Medicines Agency (EMA) for CT-P42, a biosimilar of the eye treatment Eylea (ingredient Aflibercept)
Based on the results of Phase 3 clinical trials worldwide of CT-P42, Celltrion applied with the EMA for approval of Eylea for wet macular degeneration (wAMD), central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO), diabetic macular edema (DME), and myopic choroidal neovascularization (mCNV).
Developed by Regeneron of the US, Eylea is a blockbuster drug with global sales last year of $9.75 billion. Its exclusive rights in the US expire in May next year and its patents in Europe in November 2025.
Previously, Celltrion verified CT-P42's equivalence to Eylea through a Phase 3 clinical trial with 348 patients suffering from diabetic macular edema in 13 countries, such as the Czech Republic, Hungary, Poland, and Spain.
"Following the favorable results from the global Phase 3 clinical trials for CT-P42, we have finalized the licensing applications for key markets, including the US, South Korea, and Europe," a Celltrion source said. "Our preparations to enter the global market are on track. We plan to keep expanding our product range and incrementally increase our global market influence."