On 18 February 2025, Celltrion announced that the European Commission has approved Eydenzelt® (CT-P42), biosimilar to Bayer/Regeneron’s Eylea® (aflibercept), for the treatment of multiple retinal disorders, including nAMD, macular oedema following retinal vein occlusion (RVO), diabetic macular oedema (DME) and myopic choroidal neovascularisation (myopic CNV). Eydenzelt® received a positive opinion from the CHMP in December 2024.
Eydenzelt® is the fifth aflibercept biosimilar to be approved in the EU, following: Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024) and Formycon/Klinge’s FYB203/Baiama®/Ahzantive® (January 2025). Amgen’s Pavblu® and Skojoy® received positive recommendations for marketing approval from the CHMP in January 2025, while Alvotech/Advanz Pharma and Altos Biologics have submitted MAA’s to the EMA for aflibercept biosimilars.
Celltrion filed an NDA with the FDA in June 2023 for Eydenzelt® and received Korean approval for the product in May 2024.