Sandoz and Regeneron reach agreement over biosimilar dispute

Sandoz and Regeneron Pharmaceuticals have announced an agreement settling all patent disputes between the 2 companies relating to the FDA-approved Sandoz aflibercept biosimilar.

Sandoz received FDA approval for its biosimilar aflibercept-abzv (Enzeevu) on August 12, 2024. It has the same dosage form, route of administration, and presentation as the reference medicine, Eylea, from Regeneron. The FDA provisionally determined that aflibercept-abzv would be interchangeable with Eylea, as it is currently subject to an unexpired exclusivity for the first interchangeable biosimilar products.

Regeneron initially filed patent infringement proceedings in the US Federal District Court for the District of New Jersey in August 2024 following the approval of aflibercept-abzv, pursuant to the Biologics Price Competition and Innovation Act (BPCIA). Regeneron had claimed Sandoz had infringed on up to 46 patents that expire as late as 2040, which protected Eylea.¹

According to a press release from Sandoz, under the terms of the agreement with Regeneron, Sandoz can enter its biosimilar of Eylea into the US market in the fourth quarter of 2026, or earlier in certain circumstances.

Aflibercept-abzv 2-mg vial kit and prefilled syringe for intravitreal injection is indicated to improve and maintain visual acuity in patients with neovascular age-related macular degeneration (nAMD).

In November 2024, the European Commission granted marketing authorization for aflibercept (Afqlir), a 2-mg vial kit and prefilled syringe for intravitreal injection. This is a biosimilar to the reference aflibercept, known by the brand name Eylea.²

Recently, Sandoz and Lupin agreed that Sandoz will market and commercialize Lupin’s biosimilar ranibizumab across multiple regions.³

References:

1. Sandoz reaches agreement with Regeneron, resolving all patent litigation related to its US aflibercept biosimilar. News release. Sandoz. September 9, 2025. Accessed September 9, 2025. https://www.sandoz.com/sandoz-reaches-agreement-with-regeneron-resolving-all-patent-litigation-related-to-its-us-aflibercept-biosimilar/

2. Crago SM. European Commission grants marketing authorization to aflibercept biosimilar from Sandoz Group. Ophthalmology Times. November 15, 2024. Accessed September 9, 2025. https://www.ophthalmologytimes.com/view/european-commission-grants-marketing-authorization-to-aflibercept-biosimilar-from-sandoz-group

3. Harp MD. Lupin and Sandoz sign licensing deal for biosimilar ranibizumab across multiple regions. Ophthalmology Times. August 13, 2025. Accessed September 9, 2025. https://www.ophthalmologytimes.com/view/lupin-and-sandoz-sign-licensing-deal-for-biosimilar-ranibizumab-across-multiple-regions