A strategy for the development of a biosimilar to the vascular endothelial growth factor (VEGF) inhibitor treatment for various degenerative retinal diseases, aflibercept, has been announced by Momenta Pharmaceuticals and Mylan.
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The companies’ development strategy will start with the initiation of a pivotal clinical trial in the first half of the year. This trial, a randomised, double-blind, active-control, multicentre study, will evaluate the safety, efficacy and immunogenicity of M710 compared with aflibercept in patients with diabetic macular oedema.
“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,” said Craig Wheeler, president and chief executive officer of Momenta Pharmaceuticals. “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 commented, “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. 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.”