Regeneron and Sandoz Settle Eylea Biosimilar Patent Dispute

Regeneron Pharmaceuticals and Sandoz have reached a settlement resolving all U.S. patent disputes over Sandoz's FDA-approved Eylea (aflibercept) biosimilar, Enzeevu134.

The legal dispute began in August 2024, involving claims that Sandoz's biosimilar infringed on up to 46 Eylea patents expiring as late as 2040135.

Under the settlement, Sandoz will be allowed to launch Enzeevu in the U.S. starting in Q4 2026 or earlier under certain undisclosed conditions135.

Enzeevu received FDA approval in August 2024 and is provisionally designated as interchangeable with Eylea, though interchangeability exclusivity still applies for other biosimilars13.

This agreement is expected to expand patient access to lower-cost biosimilar options and impact market dynamics in retinal disease treatments, though substantial price competition remains limited due to staggered and conditional biosimilar launches12.

Sources:

1. https://www.pharmanow.live/latest-news/sandoz-regeneron-aflibercept-settlement

2. https://www.ainvest.com/news/strategic-implications-sandoz-regeneron-patent-settlement-biosimilar-market-dynamics-2509/

3. https://eyewire.news/news/sandoz-and-regeneron-reach-agreement-on-aflibercept-biosimilar-patent-disputes

4. https://www.americanpharmaceuticalreview.com/1315-News/621276-Sandoz-Reaches-Aflibercept-Biosimilar-Patent-Agreement-with-Regeneron/

5. https://www.morningstar.com/news/dow-jones/20250909494/sandoz-reaches-pact-with-regeneron-on-enzeevu-patent-disputes