On 23 September 2024, Celltrion announced that it presented the 52-week results of its Phase 3 trial of Eydenzelt™ (CT-P42), biosimilar to Regeneron’s Eylea® (aflibercept), at the European Society of Retina Specialists (EURETINA) conference held from 19-22 September in Barcelona.
Celltrion reports that the Phase 3 trial showed that Eydenzelt™ has comparable efficacy and safety to Eylea® over 52 weeks in patients with diabetic macula oedema (DME).
Eydenzelt™ was approved in Korea in May 2024. 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.