AFLIBERCEPT-JBVF

Regeneron, already facing Eylea biosimilar competition in the U.S. from Amgen, has made a deal with Sandoz. Regeneron and Sandoz have reached a settlement that resolves all patent litigation related to the Swiss company’s biosimilar version of eye disease drug Eylea.The settlement allows Sandoz to launch its biosimilar Enzeevu in the fourth quarter of 2026 or earlier under some circumstances, the company said. Financial terms of the deal were not disclosed.The settlement ends litigation that began in August of last year, two weeks after the FDA approved Enzeevu. Regeneron claimed that the generics giant infringed 46 of its patents on Eylea, some of which expire as late as 2040.In its lawsuit, the New York company also claimed that Sandoz violated the Biologics Price Competition and Innovation Act, which accelerates the approval process for biosimilars and requires manufacturers that create them to provide information to the company that markets the reference product. Regeneron said the information was never provided.Enzeevu was approved as an interchangeable biosimilar, which means it is a clinical match to the reference product and can be substituted at the pharmacy counter without a new prescription from a doctor.In April of this year, Regeneron settled another Eylea patent dispute with Biocon Biologics, allowing the latter to commercialize its interchangeable biosimilar Yesafili in the second half of 2026.Regeneron is already dealing with Eylea biosimilar competition in the U.S. from Amgen, which began selling its version, Pavblu, in November of last year. The launch came seven weeks after a West Virginia judge blocked Regeneron’s bid for a preliminary injunction to prevent it. Amgen reported Pavblu generated revenue of $229 million in the first half of this year. Meanwhile, since Pavblu’s launch, Regeneron’s sales of Eylea have dipped dramatically, from $1.19 billion in the fourth quarter of last year to $754 million in the second quarter.Pavblu is in competition with the original 2-mg dosage version of Eylea. Regeneron’s high-dose (8-mg) version of the treatment, Eylea HD, remains under patent protection but faces stiff competition from Roche’s Vabysmo, which racked up sales of 2.1 billion Swiss francs ($2.4 billion) worldwide in the first half of this year.Meanwhile, the two Eylea formulations generated $2.5 billion in U.S. sales in the first half of this year, compared to a $3.1 billion figure for the first half of 2022, which is when Vabysmo reached the market. Regeneron is jousting with several other companies over their plans to launch Eylea biosimilars, including Biogen and Samsung Bioepis’ Opuviz. Celltrion and Formycon also have Eylea biosims in the works.Eylea works by inhibiting the growth of abnormal blood vessels in the retina and reducing fluid leakage. This mechanism helps in managing and treating conditions that lead to vision loss. In addition to its age-related macular degeneration nod, Eylea has been endorsed by the FDA to treat diabetic macular edema, retinal vein occlusion, diabetic retinopathy and retinopathy of prematurity.

Regeneron Pharmaceuticals has struck a deal with Sandoz that puts an end to their courtroom battle over Eylea (aflibercept), the former’s blockbuster anti-VEGF treatment for age-related macular degeneration (AMD) and other vision-threatening retinal diseases. Sandoz's release Tuesday announcing the agreement did not reveal any financial details.The truce clears the way for Sandoz to launch its own biosimilar, branded Enzeevu (aflibercept-abzv), in the fourth quarter of 2026, or possibly earlier under certain circumstances.The legal clash began last year, shortly after US regulators greenlit Enzeevu to improve and maintain visual acuity in patients with neovascular AMD, which is a narrower label than Eylea. The FDA also granted the biosimilar provisional "interchangeable" status with Eylea, though that designation won't take effect until the exclusivity period for the first interchangeable biosimilars runs out.Regeneron had accused Sandoz of infringing on 46 of its patents tied to Eylea, expiring as late as 2040.The settlement follows a similar pact Regeneron struck earlier this year with Biocon Biologics, which secured rights to roll out its own interchangeable rival Yesafili (aflibercept-jbvf) in the second half of 2026.Meanwhile, Regeneron is also having to contend with Amgen's anti-VEGF biosimilar. Pavblu (aflibercept-ayyh) entered the US market late last year after a US appeals court rejected Regeneron's request to block the launch. Pavblu has a broader label than Enzeevu, having been approved not only for wet AMD, but also for macular oedema, diabetic macular oedema and diabetic retinopathy. It generated sales of $130 million in the second quarter.Amid mounting pressure on its blockbuster eye franchise from Pavblu, as well as from Roche's bispecific antibody Vabysmo (faricimab), Regeneron has been counting on its newer, longer-acting version of Eylea — Eylea HD — to get an FDA nod for an extended dosing interval of up to every 24 weeks. It is already cleared for dosing as infrequently as every 16 weeks. However, in April, US regulators declined to approve Regeneron's request to add the extended dosing schedule to Eylea HD's label.The FDA also recently pushed back its decision on two other Eylea HD applications until the fourth quarter after receiving additional manufacturing information on a third-party site now owned by Novo Nordisk. For further analysis, see Vital Signs: Can Regeneron break its CRL streak?The Regeneron submissions covered a prior-approval supplement for a prefilled syringe version of Eylea HD, as well as a supplemental application seeking expanded use of Eylea HD for macular oedema following retinal vein occlusion, along with broadening the dosing schedule to include monthly dosing across existing indications.