EYLEA (Aflibercept) Biosimilar Development Updates

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).  In recent weeks, several biosimilar developers have provided status updates regarding their aflibercept biosimilar programs as part of their quarterly earnings disclosures.

On February 27, 2020, Dennis Lanfear, Chief Executive Officer of Coherus, told market analysts that the company is “now in position to initiate commercial scale, GMP manufacturing efforts in support of the expected Phase III clinical trials in 2021 with launch projected in 2025.” Coherus further indicated that this aflibercept biosimilar candidate, CHS-2020, is currently in the preclinical stage.

On February 26, Young Kwon, Chief Financial Officer and Chief Business Officer of Momenta, indicated that the company remained committed to its aflibercept biosimilar candidate, M710, its “sole remaining biosimilar in clinical development with Mylan.” Mr. Kwon stated that, even though the company had essentially exited the biosimilar business, the M710 program “remain[s] important to our strategy and … continue[s] to provide us with capital to fund the development and eventually the launches of our novel drug candidates.” In a related press release, Momenta reported that “Mylan continues its pivotal clinical trial in patients with diabetic macular edema to compare safety, efficacy and immunogenicity of M710 with EYLEA. Mylan expects to target U.S. submission in 2021.” The next day, Rajiv Malik, President of Mylan, confirmed that this biosimilar of “EYLEA remains on the track for submission in early 2021.”

Amgen also recently provided an update regarding its aflibercept program. On January 30, Amgen’s Head of R&D, Dave Reese, announced that the company was “initiating a Phase 3 study with our 7th biosimilar ABP 938, our biosimilar aflibercept or EYLEA.”