Sandoz and Regeneron Reach Agreement on Aflibercept Biosimilar Patent Disputes

Sandoz announced it has reached an agreement with Regeneron to resolve all outstanding US patent disputes related to the company’s aflibercept biosimilar, Enzeevu.

The legal proceedings originated in August 2024, when Regeneron filed a patent infringement lawsuit against Sandoz in the US District Court for the District of New Jersey. The claims, made under the Biologics Price Competition and Innovation Act (BPCIA), asserted infringement of up to 46 patents protecting Eylea (aflibercept), expiring as late as 2040.

Following months of litigation, the companies reached a settlement that allows Sandoz to enter the US market with Enzeevu in Q4 2026, or earlier under certain circumstances.

Sandoz received FDA approval for Enzeevu in August 2024. The biosimilar matches the reference product in dosage form, route of administration, and presentation, according to Sandoz. The FDA also issued a provisional determination that Enzeevu is interchangeable with Eylea—although full interchangeability is currently subject to exclusivity rights held by the first interchangeable biosimilar products.

Enzeevu is supplied as a 2 mg vial kit and pre-filled syringe for intravitreal injection for wet AMD.