On August 12, 2024, Sandoz announced that the FDA has approved ENVEEZUTM (aflibercept-abzv) 2 mg vial kit and pre-filled syringe for intravitreal injection. ENVEEZUTM is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD). According to Sandoz, the FDA also “provisionally determined that ENVEEZUTM would be interchangeable with the reference medicine [EYLEA] as it is currently subject to an unexpired exclusivity for the first interchangeable products.” Claire D’Abreu-Hayling, Chief Scientific Officer of Sandoz, stated that “[t]he US approval of Enzeevu™ is a key milestone in Sandoz efforts to significantly improve the lives of patients impacted by this incurable disease.”
Sandoz’s ENVEEZUTM is the fourth aflibercept biosimilar to be approved by the FDA, following approval of Biocon’s YESAFILI and Samsung Bioepis’s OPUVIZ in May 2024, and Formycon’s AHZANTIVE in July 2024.