Celltrion submits new drug application for Eylea biosimilar in Europe

South Korea’s Celltrion Inc. said on Friday that it has submitted an Investigational New Drug (IND) application for CT-P42, a biosimilar of Eylea (aflibercept) to treat ophthalmic diseases, to the European Medicines Agency (EMA).

The application covers the biosimilar’s approval for Eylea’s indications in Europe, including neovascular age-related macular degeneration, retinal vein occlusion macular edema, diabetic macular edema, and myopic choroidal neovascularization, the company said.

“Based on the global Phase 3 clinical trial results of CT-P42, we have sequentially completed applications for product approvals in major countries such as the United States, Korea, and Europe,” said a Celltrion spokesperson. “We are smoothly preparing for entry into the global market and aim to enhance our influence within the global market by expanding our product portfolio across various domains.”

Developed by the U.S. pharmaceutical company Regeneron, Eylea achieved worldwide sales of $9.75 billion last year.

The drug’s marketing exclusivity in the U.S. is set to expire in May next year, while its European patent is due to expire in November 2025.

Celltrion conducted a Phase 3 clinical trial with 348 patients suffering from diabetic macular edema across 13 countries, including the Czech Republic, Hungary, Poland, and Spain, demonstrating the bioequivalence of CT-P42 compared to the original medication.