Sandoz Receives FDA Approval for Eylea Biosimilar Enzeevu

The FDA has approved Sandoz's Enzeevu (aflibercept-abzv), an Eylea biosimilar, for the treatment of wet age-related macular degeneration (AMD). The approval includes both a 2 mg vial kit and a pre-filled syringe for intravitreal injection. 

The FDA provisionally determined Enzeevu would be interchangeable with the reference medicine as it is currently subject to an unexpired exclusivity for the first interchangeable biosimilar products. The FDA’s approval of Enzeevu was granted based on a comprehensive review of evidence, including extensive analytical and preclinical in vitro study data, as well as clinical results from the Mylight study, according to Sandoz.

This deal follows Sandoz's acquisition of Cimerli (ranibizumab-eqrn), a Lucentis biosimilar, from Coherus BioSciences in March for $170 million in cash, plus Cimerli inventory costs.

In a news release, Sandoz said the timing of the Enzeevu's launch will depend on various factors, including the outcome of ongoing or potential future litigation and any related settlements.