US FDA issues approval for Sandoz aflibercept-abzv (Enzeevu)
The biosimilar is indicated to improve and maintain visual acuity for patients with neovascular age-related macular degeneration
The FDA granted approval based on the totality of evidence and clinical data from the Mylight study. Image credit: ©monticellllo – stock.adobe.com
Sandoz today announced it has received FDA approval in the United States for aflibercept-abzv (Enzeevu) 2 mg vial kit and pre-filled syringe for intravitreal injection.
According to a news release, aflibercept-abzv is indicated to improve and maintain visual acuity in patients with neovascular age-related macular degeneration (nAMD).
The FDA also provisionally stated aflibercept-abzv would be interchangeable with the reference therapeutic, as it is currently subject to an unexpired exclusivity for the first interchangeable biosimilar products.1
Claire D’Abreu-Hayling, chief scientific officer of Sandoz, lauded the announcement. She noted that nAMD continues to be a leading cause of vision impairment in patients over 50 years in North America.
“This condition affects millions of people, leading to significant challenges in their daily lives due to the progressive loss of central vision,” D’Abreu-Hayling said in a news release. “The US approval of Enzeevu is a key milestone in Sandoz efforts to significantly improve the lives of patients impacted by this incurable disease.”
According to the news release from Sandoz, the FDA approval of aflibercept-abzv will advance the company’s growth strategy by further extending its US ophthalmology portfolio. The launch of aflibercept-abzv will depend on several factors, including the progress and outcome of pending or potential future related litigations or any potential settlements.1
Jeff Todd, president and CEO of Prevent Blindness, welcomed news of the FDA approval.
“As sight disappears, so may a person’s connection to the world,” Todd said. “We welcome all treatment options that help maintain vision and meet the unique needs of the individual so those living with wet AMD can potentially maintain their independence longer.”
Todd pointed out there currently is no cure for the disease and long-term treatment can be costly.
“Having more FDA-approved options, including biosimilars, can help make healthcare more person-centered and affordable,” he said.
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 (NCT04864834), an international, multicenter, randomly assigned, double-masked, 2-arm parallel study in 485 patients with nAMD with a duration of 52 weeks. It confirmed equivalent efficacy and comparable safety and immunogenicity for aflibercept-abzv and the reference medicine Eylea.1
This approval comes in the wake of the ranibizumab-eqrn (Cimerli) business by Sandoz in the United States earlier in 2024.
