The options for treatment of neovascular age-related macular degeneration (nAMD) continue to grow with the United States Food and Drug Administration (FDA) approving Enzeevu (aflibercept-abzv, Sandoz) 2mg vial kit and pre-filled syringe for intravitreal injection.1

Additionally, the FDA provisionally determined Enzeevu would be interchangeable with the reference medicine Eylea (aflibercept, Bayer), as it is currently subject to an unexpired exclusivity for the first interchangeable biosimilar products.

The FDA granted approval based on comprehensive analytical and preclinical in vitro study data, as well as clinical data from the Mylight study,2 an international, multicentre trial that ran over 52 weeks. The Mylight study confirmed equivalent efficacy, as well as comparable safety and immunogenicity for Sandoz biosimilar aflibercept and the reference medicine as per Eylea’s approved treatment regimen in patients with nAMD.2

The launch of Enzeevu will be dependent on several factors, including the progress and outcome of pending or potential future related litigations or any potential settlements.

References available at mivision.com.au.