Regeneron challenges Sandoz over new Eylea generic

Regeneron Pharmaceuticals has initiated a lawsuit in a New Jersey federal court against Sandoz. The accusation revolves around the recent approval of Sandoz’s biosimilar, Enzeevu (aflibercept-abzv), which Regeneron claims infringes on 46 of its patents related to its high-selling eye treatment, Eylea (aflibercept). This legal action follows the FDA’s approval of Enzeevu in early August, marking it as the fourth biosimilar version of Eylea to receive regulatory clearance in the U.S. in recent times.

In its legal filing, Regeneron alleges that Sandoz did not comply with the information-sharing requirements dictated by the Biologics Price Competition and Innovation Act (BPCIA). According to Regeneron, Sandoz’s failure to provide necessary details about its product forced them to speculate about which patents might be infringed. The disputed patents cover a broad spectrum of attributes related to Eylea, including its composition, manufacturing processes, formulations, and methods of use.

Regeneron is seeking both injunctive relief and damages from Sandoz. The pharmaceutical company is also open to the possibility of enhanced damages if the court determines that Sandoz’s infringement was willful. The exact timing for Enzeevu's market launch remains unclear. Sandoz has indicated that the launch will depend on numerous factors, including the outcomes of ongoing or potential future litigations and any possible settlements.

The context of this lawsuit is shaped by recent decisions in similar cases. A judge in West Virginia granted Regeneron a permanent injunction against the launch of Biocon's Yesafili (aflibercept-jbvf) and a preliminary injunction against Samsung Bioepis/Biogen’s Opuviz (aflibercept-yszy). Both of these products have achieved interchangeable status with Eylea. To limit the competition, Regeneron had focused its legal arguments on treatment claims under a specific U.S. patent, No. 11,084,865, which encompasses VEGF antagonist formulations suitable for intravitreal administration.

This series of legal battles underscores the fierce competition in the biosimilar market and highlights the strategies companies like Regeneron employ to protect their market share. With the growing presence of biosimilars, original developers are increasingly turning to legal channels to delay or prevent the entry of these alternatives. The outcome of these litigations will likely influence market dynamics and the commercial strategies of biosimilar developers looking to enter lucrative markets dominated by products like Eylea.