Yesterday, Momenta Pharmaceuticals and Mylan announced a development strategy for M710, a proposed biosimilar of Regeneron’s Eylea® (aflibercept), including their plan to initiate a pivotal clinical trial in the first half of this year. According to the joint press release, the trial will be a randomized, double-blind, active-control, multi-center study in patients with diabetic macular edema to compare the safety, efficacy and immunogenicity of M710 with Eylea®.
Eylea® is a recombinant fusion protein that inhibits vascular endothelial growth factor (VEGF) 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 in patients with DME. Eylea® first received FDA approval in 2011. Regeneron reported net sales of Eylea® in the U.S. of about $3.3 billion for 2016. Eylea® is sold outside the U.S. through a collaboration with Bayer, which, according to Regeneron, recorded net sales of about $1.8 billion for 2016.