Sandoz, a Novartis division, has 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 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.
“nAMD accounts for 10% of all age-related macular degeneration cases, but is responsible for 90% of AMD-related blindness,” said Florian Bieber, Global Head of Biopharmaceuticals Development, Sandoz. “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 nAMD1.
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.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox! Sign up now!