Sandoz Settles Patent Disputes With Regeneron, Eyes 2026 U.S. Launch Of Eylea® Biosimilar

Sandoz, a global leader in generics and biosimilars, announced it has reached a settlement with Regeneron Pharmaceuticals resolving all U.S. patent disputes related to its FDA-approved aflibercept biosimilar. The litigation, initiated by Regeneron in August 2024 under the Biologics Price Competition and Innovation Act (BPCIA), involved up to 46 patents protecting Eylea® through 2040.

Under the settlement, Sandoz may launch its aflibercept biosimilar Enzeevu™ in the U.S. starting Q4 2026, or potentially earlier under certain conditions. Enzeevu™, which gained FDA approval in August 2024, mirrors Eylea® in dosage form, route of administration, and presentation. The FDA has also provisionally determined Enzeevu™ to be interchangeable with the reference product, though final interchangeability exclusivity remains in effect for other approved biosimilars.

The agreement marks a significant milestone for Sandoz in expanding its ophthalmology portfolio and reinforces its mission to increase patient access to affordable, high-quality biosimilars. The U.S. entry of aflibercept biosimilars is expected to provide more treatment options for patients while easing healthcare costs in ophthalmology.