Regeneron has settled its patent dispute with Celltrion, giving the go-ahead for another biosimilar to its blockbuster eye drug Eylea (aflibercept) to hit the U.S. market in just over a year.
The deal settles all patent litigation between the two companies and allows Celltrion to launch its biosimilar on Dec. 31, 2026, Regeneron said in an Oct. 20 statement. Other terms of the agreement, including financial considerations, remain confidential.
South Korean drugmaker Celltrion won U.S. approval for its biosimilar on Oct. 9, with the FDA signing off on the drug's use in the same indications Eylea holds for neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy.
The Eylea biosim will be marketed under the name Eydenzelt. In trials, the drug “met the predefined equivalence criteria” to Eylea and showed similar results to the reference product in secondary endpoints of efficacy, safety and immunogenicity, according to Celltrion.
Celltrion is the latest to win an FDA nod for its aflibercept product out of the biosim developers Regeneron has sued. Celltrion, Sandoz, Amgen, Formycon, Samsung Bioepis and Mylan Pharmaceuticals—plus partner Biocon Biologics—have all been the subjects of Regeneron’s attempts to block out the biosimilar competition in the courts.
Only Amgen, however, has emerged with a legal victory over Regeneron, enabling the company to sell the only marketed Eylea biosimilar in the U.S. But, with Regeneron's recent settlements, the competition is poised to intensify next year.
Sandoz’s Enzeevu, for one, is allowed to launch in the fourth quarter of 2026, or earlier in “certain circumstances,” under that company's recent agreement with Regeneron. Enzeevu is an interchangeable biosimilar, meaning it can be substituted at the pharmacy counter without a new prescription from a doctor.
Biocon and Mylan became the first to settle with Regeneron back in April, allowing their interchangeable Yesafili to launch in the second half of 2026.
Regeneron is still blocking Samsung Bioepis’ Opuviz and Formycon’s Ahzantive biosimilars from launching and hasn’t given up on its dispute with Amgen, filing another complaint as recently as June. Eylea pulled down $1.1 billion in U.S. sales last quarter, a 25% fall from the same period last year.