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Clinical Trials

Momenta, Mylan to start trial of biosimilar to eye drug Eylea

PBR Staff Writer Published 04 January 2018

Momenta Pharmaceuticals and Mylan have unveiled plans to commence pivotal clinical study of a biosimilar to Regeneron’s eye drug Eylea (aflibercept).

The companies have announced a development strategy for M710, a proposed biosimilar to Eylea injection.

Eylea is a vascular endothelial growth factor (VEGF) inhibitor developed to treat neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy in patients with diabetic macular edema.

The partnership is planning to start a clinical trial in patients in the first half of this year.

The randomized, double-blind, active-control and multi-center trial will recruit patients with diabetic macular edema to compare the safety, efficacy and immunogenicity of M710 with Eylea.

Momenta Pharmaceuticals president and CEO Craig Wheeler said: “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.”

Mylan president Rajiv Malik said: “Advancing a biosimilar to EYLEA to the clinical trial period in the first half of the year is an exciting milestone in the development of this important product.”

Momenta uses its technology to develop generic versions of complex drugs, biosimilar and potentially interchangeable biologic. It is also involved in the discovery and development of novel therapeutics for autoimmune indications.

Mylan markets more than 7,500 products, including antiretroviral therapies, in around 165 countries and territories.

A Logistics. Photo: courtesy of Hutchison Port Holdings Limited.