Aflibercept-mrbb

The FDA has approved Sandoz's Enzeevu (aflibercept-abzv), making it the fourth biosimilar version of Regeneron Pharmaceuticals' eye disease drug Eylea (aflibercept) to receive US regulatory clearance in recent weeks. However, Enzeevu carries a narrower label than other approved biosimilars of the anti-VEGF therapy.Enzeevu is approved to improve and maintain visual acuity in patients with neovascular age-related macular degeneration (AMD). The FDA has also provisionally determined that Enzeevu would be interchangeable with the original medicine, though it can't currently be marketed as interchangeable due to existing exclusivity rights for the first interchangeable biosimilars.The decision announced Monday follows closely on the heels of three other Eylea biosimilar approvals: Biocon's Yesafili (aflibercept-jbvf) and Samsung Bioepis/Biogen's Opuviz (aflibercept-yszy) – both of which have interchangeable status – as well as Formycon/Klinge Biopharma's Ahzantive (aflibercept-mrbb), which along with AMD are all also authorised for macular oedema following retinal vein occlusion, diabetic macular oedema and diabetic retinopathy.Legal action ongoingThe rapid succession of approvals comes as Regeneron has been actively pursuing legal action against biosimilar developers, including seeking injunctions to delay market entry. Eylea's exclusivity ran out around mid-May, with Yesafili and Opuviz securing FDA approvals in the days following. Ahzantive was greenlit about a month later.However, a judge in the US District Court for the Northern District of West Virginia awarded Regeneron a permanent injunction in June against the launch of Yesafili and a preliminary injunction in its lawsuit against Opuviz. Regeneron sought to block sales of the potential Eylea rivals by narrowing its bid to treatment claims under a single US patent, No. 11,084,865, which covers VEGF antagonist formulations suitable for intravitreal administration.As a result, the timing of Enzeevu's market entry remains up in the air. "Launch timing will be dependent on several factors, including the progress and outcome of pending or potential future related litigations or any potential settlements," Sandoz said in a statement.Eylea has been a significant revenue driver for Regeneron, with US sales reaching $5.7 billion in 2023. However, the drug faces increasing competition not only from biosimilars, but also from Roche's Vabysmo (faricimab-svoa). In response, Regeneron has been promoting a high-dose version of Eylea, which brought in $304 million in second-quarter sales of this year, according to the company's most recent earnings report.