Sandoz Begins Late-Stage Clinical Development for Biosimilar Aflibercept

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Sandoz will soon begin enrolling patients with neovascular age-related macular degeneration in a Phase III study with its proposed biosimilar to aflibercept.

Sandoz, a Novartis division, announced on May 3, 2021 that it is progressing into late-stage clinical development for its proposed biosimilar aflibercept (brand name EYLEA under Regeneron Pharmaceuticals). Sandoz will soon begin enrolling the first patient in a clinical Phase III confirmatory efficacy and safety study, the company stated in a press release.

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, in the press release. “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.”


Source: Novartis