Aflibercept

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.