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  • Celltrion applies for approval of its Eylea biosimilar in KR
  • by Jung, Sae-Im | translator Kim, Jung-Ju | Jul 27, 2023 05:40am
Treatment for wet age-related macular degeneration and diabetic macular edema
Plans to apply for approval around the globe, starting with the U.S., then Europe
On the 26th, Celltrion announced that it had completed applying for the marketing authorization of 'CT-P42,' its biosimilar to the eye disease treatment ¡®Eylea (aflibercept).¡¯

Based on its global Phase III trial, Celltrion applied to be approved for all Eylea indications including as a treatment for wet age-related macular degeneration (wAMD) and diabetic macular edema (DME).

Celltrion confirmed the bioequivalence and similarity of CT-P42 in a Phase III trial that was conducted on 348 patients with diabetic macular edema in 13 countries, including the Czech Republic, Hungary, Poland, and Spain.

In June, the company submitted an aBLA (abbreviated biologic license application) for CT-P42 to the US Food and
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