EYLEA (Aflibercept) Biosimilar Development Updates (Part 2)

Regeneron’s EYLEA (aflibercept) was approved by the U.S. FDA on November 18, 2011 and is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR).

As previously reported, Momenta in collaboration with Mylan began Phase III clinical trials of their aflibercept biosimilar candidate, M710 (also referred to as MYL-1701P) in 2018.  Clinical trials in patients with DME are on-going and, as of March, Mylan was targeting submission for FDA approval in 2021.

Clinicaltrials.gov lists three more developers who have entered Phase III clinical trial for their respective aflibercept biosimilar candidates.  These clinical trials are all in patients with Wet AMD.  These include: ABP 938 (Amgen), SB15 (Samsung Bioepis/Biogen), and SCD411 (Sam Chun Dang Pharm).  According to statements in its fourth quarter 2019 earnings report, Coherus expects to enter Phase III clinical trials for its aflibercept biosimilar candidate, CHS-2020, but not until 2021.