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Approval Alert: Celltrion’s Aflibercept Biosimilar Approved in Korea

May 30, 2024

On 30 May 2024, the Korea IT Times reported that Celltrion announced it received domestic approval from South Korea’s Ministry of Food and Drug Safety for EydenzeltTM (CT-P42), biosimilar to Regeneron’s Eylea® (aflibercept).  Eydenzelt was approved for the same indications as Eylea® including wet macular degeneration and diabetic macular oedema. 

Celltrion sought EU marketing authorisation for CT-P42 in November 2023 and filed an NDA with the FDA in June 2023.  

In November 2023 and May 2024, Regeneron commenced US BPCIA proceedings against Celltrion in the US District Court (Northern District of West Virginia), alleging infringement of 38 and 25 patents respectively relating to aflibercept.  These proceedings are ongoing.