On August 12, 2024, Sandoz (Basel, Switzerland), a generic and biosimilar pharmaceuticals company, has received FDA approval for Enzeevu™ (aflibercept-abzv, 2mg) for the intravitreal injection treatment of neovascular age-related macular degeneration (nAMD).
The FDA’s endorsement of Enzeevu comes with an additional provisional determination that it is interchangeable with the reference medicine, Eylea® (Regeneron/Bayer). This interchangeability is particularly noteworthy as it is subject to an unexpired exclusivity for the first interchangeable biosimilar products, a factor that may influence the market landscape.
In a strategic move earlier this year, Sandoz acquired CIMERLI® (ranibizumab-eqrn) from Coherus BioSciences (Redwood City, California, USA), an interchangeable Lucentis® (Genentech/Novartis) biosimilar, which fortified its ophthalmology portfolio in the United States. The integration of CIMERLI and its field force employees has set the stage for Enzeevu’s anticipated market entry, bolstering the company’s position in a competitive landscape.
Enzeev is designed to treat nAMD, a debilitating condition where abnormal blood vessels grow under the retina, causing vision impairment. The active ingredient, aflibercept, is a recombinant fusion protein that targets vascular endothelial growth factor A (VEGF-A) and placental growth factor (PlGF). By inhibiting these factors, Enzeevu aims to slow disease progression and improve visual acuity through its intravitreal injections.
Noting that nAMD continues to be a leading cause of vision impairment in North American patients over 50, Claire D’Abreu-Hayling, chief scientific officer at Sandoz highlighted the significance of the FDA approval in a news release, “This condition affects millions of people, leading to significant challenges in their daily lives due to the progressive loss of central vision. The US approval of Enzeevu is a key milestone in Sandoz efforts to significantly improve the lives of patients impacted by this incurable disease.”
The FDA approval was granted based on robust data, including results from the Mylight study. This international, multicenter, randomized trial involved 485 patients and confirmed that Enzeevu demonstrated equivalent efficacy, safety and immunogenicity compared to Eylea.1
“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. At this time, there is no cure for this disease and long-term treatment can be costly,” said Jeff Todd, J.D., president and CEO of Prevent Blindness, in a news release. “Having more FDA-approved options, including biosimilars, can help make healthcare more person-centered and affordable.”
With the FDA’s approval, Enzeevu is expected to be a significant growth driver for Sandoz, further extending its reach in the U.S. ophthalmology sector. The timing of its launch will depend on various factors, including ongoing litigation and potential settlements.
This development underscores Sandoz’s commitment to expanding access to essential treatments and driving forward its strategy in the ophthalmic domain. As the biosimilar market evolves, Enzeevu represents a crucial advancement in the fight against vision impairment caused by nAMD.
Reference
- United States Clinical Trials Registry [Internet]. 2021 May 12 – 2023 May 10. Identifier NCT04864834, Phase III study assessing the efficacy, safety and immunogenicity of SOK583A1 versus Eylea® in patients with neovascular age-related macular degeneration (Mylight); 2024 March 26 [cited 2024 August 13]. Available at: https://clinicaltrials.gov/study/NCT04864834
