Late-stage clinical development plans underway for proposed biosimilar aflibercept

Sandoz, a Novartis division, announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept.

According to the company, it will begin enrolling the first patients in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study.

Aflibercept is indicated to improve visual acuity in patients with neovascular age-related macular degeneration (nAMD), diabetic macular oedema, macular oedema secondary to retinal vein occlusion, and other specific neovascular retinal diseases.

MYLIGHT is a randomly assigned double-blind parallel 2-arm study, which is projected to include 460 patients across 20 countries. The MYLIGHT study will be conducted in neovascular (wet) age-related macular degeneration.

According to the company, nAMD patients will be randomly assigned to receive either biosimilar aflibercept or the reference medicine for 48 weeks. The primary endpoint is the mean change in best corrected visual acuity (BCVA) score from baseline to week 8, using a standard test chart (EDTRS).

The global development program for Sandoz’ biosimilar aflibercept was developed in consultation with major regulatory agencies and the results from this clinical study are expected to support regulatory submissions.

“nAMD accounts for 10% of all age-related macular degeneration cases, but is responsible for 90% of AMD-related blindness,” Florian Bieber, global head of Biopharmaceuticals Development at Sandoz, said in a statement. “Aflibercept is a key treatment in ophthalmology. The initiation of this study marks an important milestone in the development of our biosimilar aflibercept. As with all our biosimilar programs, we aim to expand access to high-quality, more affordable biologics.”

MYLIGHT is part of a comprehensive biosimilar development program including analytical, preclinical and clinical data. The study aims to confirm that the proposed biosimilar has equivalent efficacy and comparable safety to the reference medicine in patients with nAMD.

Sandoz biosimilars help patients to access advanced biologic medicines more sustainably and affordably. The Sandoz division has a leading global portfolio with eight marketed biosimilars and a further 15-plus in various stages of development.

The Sandoz biosimilar pipeline is a blend of in-house development and collaborations, both for co-development and commercialization, targeting key biologics in oncology, immunology, endocrinology and underserved complex disease areas.

According to the company, aflibercept binds and inhibits ocular VEGF-A, and prevents abnormal growth of blood vessels in the choroid which impact visual function. It improves visual acuity in patients with neovascular retinal diseases.