Sandoz: Enzeevu approved in US

(CercleFinance.com) - Sandoz announces that the US FDA has approved the intravitreal injection of Enzeevu with a pre-filled syringe, to improve and maintain visual acuity in patients with neovascular age-related macular degeneration (AMD).


The US health authority granted this indication on the basis of the Mylight study, which confirmed equivalent efficacy, as well as comparable safety and immunogenicity to its reference drug Eylea.

In addition, the FDA has provisionally determined that Enzeevu would be interchangeable with the reference drug, as it is currently subject to unexpired exclusivity for the first interchangeable biosimilar products.

Key value driver for Sandoz biosimilars, this approval marks a major step in advancing its growth strategy by further expanding its leading ophthalmology portfolio in the US.


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