Sandoz's Enzeevu is fourth Eylea biosimilar approved in US

The FDA has recently granted approval to Sandoz's Enzeevu (aflibercept-abzv), making it the fourth biosimilar version of Regeneron Pharmaceuticals' eye disease treatment Eylea (aflibercept) to receive regulatory clearance in the United States within a short time frame. However, Enzeevu has a more limited label compared to other biosimilars of the anti-VEGF therapy. Specifically, Enzeevu is approved to enhance and maintain visual acuity in patients suffering from neovascular age-related macular degeneration (AMD). Although the FDA has provisionally determined that Enzeevu could be interchangeable with the original medication, it cannot be marketed as such due to existing exclusivity rights for the first interchangeable biosimilars.

This recent decision by the FDA comes on the heels of three other Eylea biosimilar approvals. These include Biocon’s Yesafili (aflibercept-jbvf) and Samsung Bioepis/Biogen's Opuviz (aflibercept-yszy), both of which hold interchangeable status, as well as Formycon/Klinge Biopharma's Ahzantive (aflibercept-mrbb). Aside from AMD, these biosimilars are all approved for treating macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.

The rapid succession of these approvals occurs amidst ongoing legal battles initiated by Regeneron against biosimilar developers. Regeneron has been actively seeking legal injunctions to delay the market entry of these biosimilars. Eylea's market exclusivity expired around mid-May, with Yesafili and Opuviz obtaining FDA approvals shortly thereafter. Ahzantive received its approval approximately one month later. However, a judge in the US District Court for the Northern District of West Virginia issued a permanent injunction in June against the launch of Yesafili and a preliminary injunction against Opuviz. Regeneron aimed to block the sales of these potential Eylea competitors by focusing its legal efforts on treatment claims covered by a specific US patent, No. 11,084,865, which pertains to VEGF antagonist formulations suitable for intravitreal administration.

Due to these ongoing legal issues, the exact timing for Enzeevu’s market entry remains uncertain. Sandoz has indicated that the launch timing will depend on several factors, including the progress and outcome of pending or potential future litigations and any possible settlements.

Eylea has been a major revenue generator for Regeneron, with US sales reaching $5.7 billion in 2023. However, the drug is facing increasing competition not only from biosimilars but also from Roche’s Vabysmo (faricimab-svoa). In response to this competition, Regeneron has been promoting a high-dose version of Eylea, which brought in $304 million in sales during the second quarter of this year, according to the company’s latest earnings report.

This environment of rapid biosimilar approvals and ongoing legal battles underscores the competitive landscape for eye disease treatments. As new biosimilars like Enzeevu gain approval, the dynamics of market competition will continue to evolve, presenting both challenges and opportunities for pharmaceutical companies involved in this therapeutic area.