Sandoz confirms late-stage clinical development plans for proposed biosimilar aflibercept.

Sandoz, a Novartis division, announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly. Aflibercept (Eylea) 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 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. About MYLIGHT :The MYLIGHT is a randomized, 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 as this is an adequately sensitive indication and representative of many patients who are treated with the medicine. nAMD patients will be randomized 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. The U.S. patents for Lucentis and Eylea expired in 2020, and their European patents will expire in 2022 and 2025, respectively.Eylea also comes off patent in 2022 in China and Japan.