Seen as key biosimilar growth driver in the US this year (Il Sole 24 Ore Radiocor) - Bern, 12 Aug - Swiss generics and biosimilar drug maker Sandoz aid that the US Food and Drug Administration (FDA) approved the Enzeevu (aflibercept-abzv) 2 mg vial kit and pre-filled syringe for intravitreal injection 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.

Enzeevu is a key biosimilar value driver for the company and this approval is a major step in advancing the Sandoz growth strategy by further extending its leading US ophthalmology portfolio. Launch timing will be dependent on several factors, including the progress and outcome of pending or potential future related litigations or any potential settlements.

nAMD, also known as wet AMD, is a subtype of age-related macular degeneration (AMD), which is a leading cause of vision impairment in patients over 50 years in North America.

The FDA granted approval based on the totality of evidence, including comprehensive analytical and preclinical in vitro study data, as well as clinical data from the Mylight study This approval follows the acquisition of the Cimerli (ranibizumab-eqrn) business by Sandoz in the US earlier in 2024.

AAA-Sch

(RADIOCOR) 12-08-24 11:05:45 (0181) 5 NNNN