Sandoz further strengthening US biosimilar position

12 August 2024

The US Food and Drug Administration (FDA) has approved Enzeevu (aflibercept-abzv) 2mg vial kit and pre-filled syringe for intravitreal injection, developed by Swiss biosimilars company Sandoz (SIX: SDZ).

The reference product is Eylea, which is developed and marketed by Regeneron (Nasdaq: REGN) and Bayer (BAYN: DE).

Enzeevu is indicated to improve and maintain visual acuity in patients with neovascular age-related macular degeneration (nAMD). In addition, 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.

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