On April 3, 2023, Celltrion announced positive 24-week results from its global Phase III Clinical Trial of CT-P42 (aflibercept), a biosimilar referencing Regeneron’s EYLEA. The trial is a 52-week trial in 348 patients with diabetic macular edema (DME) across thirteen countries. The primary endpoint was the change in best corrected visual acuity measured at week 8 from baseline, comparing CT-P42 and EYLEA. Results of the study showed that CT-P42 met the predefined equivalence criteria, and secondary endpoints of efficacy, safety, and immunogenicity also showed similar trends to EYLEA.
Celltrion also announced its intent to complete the remainder of the Phase III trial and file for licensure of CT-P42 in the U.S. and Europe later this year.