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Celltrion applies for approval of CT-P42, biosimilar to Regeneron’s Eylea® (aflibercept)

Jul 26, 2023

According to the Korea Biomedical Review Celltrion has applied to the Ministry of Food and Drug Safety for marketing authorisation of its CT-P42, biosimilar to Regeneron’s Eylea® (aflibercept) for all of Eylea®’s indications approved in Korea, including wet age-related macular degeneration and diabetic macular edema.

Celltrion announced the results of its Ph III trials of CT-P42 on 3 April 2023 which demonstrated equivalence and similarity to Eylea®.  CT-P42 met secondary endpoints of efficacy, safety, and immunogenicity when compared with Regeneron’s Eyela®.

On 30 June 2023, Celltrion filed an NDA for CT-P42 with the FDA, and  announced that it intends to file an ABLA in at least the US and Europe later in 2023.