Sandoz and Regeneron Settle U.S. Patent Disputes Over Aflibercept Biosimilar Enzeevu

Sandoz has announced a settlement agreement with Regeneron, resolving all ongoing U.S. patent litigation concerning its aflibercept biosimilar, Enzeevu. The agreement clears the way for Sandoz to enter the U.S. market with its biosimilar in late 2026.

Background of the Legal Dispute

The legal proceedings began in August 2024, when Regeneron filed a patent infringement lawsuit against Sandoz in the U.S. District Court for the District of New Jersey. The lawsuit was filed under the Biologics Price Competition and Innovation Act (BPCIA) and cited alleged infringement of up to 46 patents related to Eylea (aflibercept), with some patent protections extending through 2040.

Terms of the Settlement Agreement

Following several months of litigation, the companies reached a settlement that will allow Sandoz to commercialize Enzeevu in the United States starting in Q4 2026, or potentially earlier under certain defined conditions.

FDA Approval and Interchangeability Status

Enzeevu received FDA approval in August 2024. According to Sandoz, the biosimilar matches the reference product (Eylea) in dosage form, route of administration, and presentation.

The FDA also issued a provisional determination that Enzeevu is interchangeable with Eylea. However, full interchangeability status is currently limited by exclusivity rights held by the first approved interchangeable biosimilar products, and Enzeevu’s interchangeable designation will remain provisional until that exclusivity period ends.

Product Details

Enzeevu is supplied in two formats for intravitreal injection for the treatment of wet age-related macular degeneration (AMD): a 2 mg vial kit and a 2 mg pre-filled syringe.