Momenta Pharmaceuticals (NSDQ:MNTA) and Mylan (NSDQ:MYL) announced yesterday that they plan to launch a pivotal trial in the first half of 2018 for a proposed biosimilar to Regeneron‘s (NSDQ:REGN) blockbuster drug, Eylea.
Eylea, a VEGF-inhibitor designed to treat wet age-related macular degeneration and diabetic macular edema, has little competition on today’s market. The drug brought in more than $5 billion for Regeneron in 2016.
The trial that Mylan and Momenta are planning for M710 is slated to compare the safety, efficacy and immunogenicity of the biosimilar with Eylea.
“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,” Momenta’s president & CEO, Craig Wheeler, said in prepared remarks.
“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,” Mylan’s president Rajiv Malik added. “We are proud of the significant investments we’ve made in building one of the industry’s most robust biosimilar pipelines, and we look forward to being at the forefront of offering patients a more affordable version of this complex product.”
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