FDA approves Enzeevu, aflibercept biosimilar for neovascular AMD
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The FDA approved the Enzeevu 2 mg vial kit and prefilled syringe for intravitreal injection for the treatment of neovascular age-related macular degeneration, according to a press release from Sandoz.
The biosimilar Enzeevu (aflibercept-abzv) is indicated for the improvement and maintenance of visual acuity in patients with neovascular AMD. The FDA also provisionally determined that Enzeevu is interchangeable with Eylea (aflibercept, Regeneron). The approval is supported by clinical data from the Mylight study, as well as analytical and preclinical in vitro study data.
“The U.S. approval of Enzeevu is a key milestone in Sandoz efforts to significantly improve the lives of patients impacted by this incurable disease,” Claire D’Abreu-Hayling, chief scientific officer at Sandoz, said in the release.
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