Momenta and Mylan Announce Clinical Trial of Proposed Aflibercept Biosimilar

Momenta Pharmaceuticals and Mylan have announced that they will begin a pivotal clinical trial of their jointly developed M710, a proposed biosimilar of the anti—vascular endothelial growth factor (anti-VEGF) therapy aflibercept, referenced on Eylea.

The reference aflibercept is approved to treat neovascular age-related macular degeneration (AMD), macular edema following retinal vein occlusion, diabetic macular edema (DME), and diabetic retinopathy in patients who have DME.

The trial, slated to begin in the first half of 2018, will be a randomized, double-blind, active-control, multi-center study in patients with DME, and will compare the safety, efficacy, and immunogenicity of M710 with its reference.

“Expanding treatment access and providing high-quality, affordable drugs for patients is a key attribute of our biosimilars business and an important business objective at Momenta. We believe our proposed biosimilar to Eylea, in collaboration with Mylan, is an attractive program with limited biosimilar competition, which could result in a first to market advantage,” said Craig Wheeler, president and CEO of Momenta Pharmaceuticals.

If the drug makers achieve their goal in reaching the market first with a biosimilar aflibercept, Momenta and Mylan would be well positioned to capture a portion of Eylea’s strong global sales; in 2016, the drug earned Regeneron $5.2 billion. Also in the race to bring an aflibercept biosimilar to market is German drug maker Formycon, which reports that it is in preclinical development with its own molecule, FYB203.

Additional biosimilars targeting VEGF are in the pipeline as well; Roche’s Lucentis (ranibizumab), which also treats AMD, macular edema following retinal vein occlusion, DME, and diabetic retinopathy in patients with DME, faces challenges from Formycon’s FYB201, Samsung Bioepis’ SB11, Pfenex’s PF582, and Intas’ Razumab (approved as a “similar biologic” in India in 2015).

However, recent analyses have suggested that both aflibercept and ranibizumab may not be as cost effective as another anti-VEGF, bevacizumab (Avastin), in treating these eye conditions. A longitudinal study of hospital costs, set in England’s National Health Service, found that bevacizumab, which is approved for the treatment of cancer but not for the treatment of ophthalmological indications, can be divided into small doses for ophthalmic therapy and can be used to lower the cost burden of anti-VEGF treatment, thereby increasing patient access to quality care.

In the United States, the first bevacizumab biosimilar, Mvasi (sponsored by Amgen) was approved in September 2017. Like its reference, Avastin, the anti-VEGF does not carry an FDA approval for treating eye conditions.