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  • Celltrion gains EU approval for Eylea biosimilar Eyedenzelt
  • by Chon, Seung-Hyun | translator Hong, Ji Yeon | Feb 17, 2025 05:53am
The approval was granted within two months of receiving the authorization recommendation from the CHMP¡¦will launch in the market worth KRW 12 trillion
On February 14, Celltrion announced that it had secured the marketing authorization for the Eylea biosimilar Eyedenzelt from the European Commission. Two months after receiving the recommendation for marketing authorization from the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) in December, the drug was granted the final approval.

Eyedenzelt is approved for the original drug's major indications to treat wet (neovascular) age-related macular degeneration (wAMD), retinal vein occlusion, diabetic macular edema (DME), and myopic choroidal neovascularization. In 2023, Eylea recorded sales of approximately KRW 13 trillion globally.

Celltrion confirmed the equivalence of Eyeden
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