Regeneron is going after Sandoz in a New Jersey federal court over Sandoz’s recently-approved drug Enzeevu, a biosimilar to Regeneron’s blockbuster eye treatment Eylea.
Eylea, which has collected indications in several eye disorders since its initial approval in neovascular (wet) age-related macular degeneration in 2011, hauled in more than $12 billion for Regeneron in 2022 and 2023. In the second quarter of this year, US net sales for both doses of the drug increased 2% to $1.53 billion.
Eylea HD, a higher dose, was approved by the FDA in August 2023, and it’s Regeneron’s hope that it would become the standard of care for these retinal diseases.
In a filing dated Monday, Regeneron asked the US District Court for the District of New Jersey to block Sandoz’s Enzeevu as well as for monetary damages. Regeneron alleged that Sandoz didn’t provide information about its biosimilar as it should have done under the Biologics Price Competition and Innovation Act, which spells out the pathway by which biosimilars are approved. Enzeevu was approved earlier this month.
According to the lawsuit, by Sandoz filing its biosimilar application with the FDA “and failing to provide the statutorily mandated information,” Sandoz “violated, and will continue to violate, this statute and infringe Regeneron’s patent rights.”
According to the complaint, Regeneron has 46 patents for Eylea, all of which Sandoz has violated.
A representative for Sandoz told Endpoints News it does not comment on pending litigation.
Sandoz is not the first to win approval for an Eylea biosimilar — in May, the FDA approved Biocon Biologics’ Yesafili and Samsung Bioepis and Biogen’s Opuviz. But because of remaining patents on Eylea and a win for Regeneron in court against Mylan (now Viatris) last year, analysts don’t expect either biosimilar to launch until 2027.