Sandoz has reached an agreement with Regeneron Pharmaceuticals, Inc., to resolve all patent disputes between the two companies relating to the US Food and Drug Administration (FDA)-approved Sandoz aflibercept biosimilar.
Patent infringement proceedings were initially filed by Regeneron in the US Federal District Court for the District of New Jersey in August of 2024, pursuant to the Biologics Price Competition and Innovation Act (BPCIA). Resolution of the BPCIA litigation followed months of vigorous defense by Sandoz against claims by Regeneron that the company infringed up to 46 patents expiring as late as 2040, protecting reference medicine Eylea®. Under the terms of the agreement, Sandoz may enter the US market with a biosimilar version of Eylea® in the fourth quarter of 2026, or earlier in certain circumstances.
Sandoz received FDA approval of its aflibercept biosimilar Enzeevu™ on August 12, 2024. It has the same dosage form, route of administration, and presentation as the reference medicine. In addition, the FDA provisionally determined Enzeevu™ would be interchangeable with the reference medicine, as it is currently subject to an unexpired exclusivity for the first interchangeable biosimilar products.
Bringing biosimilar aflibercept to market further strengthens Sandoz leadership in ophthalmology in the US, expands its biosimilar portfolio, and advances the company’s Purpose of pioneering access for patients, by providing affordable high-quality medicines.
Enzeevu™ (aflibercept-abzv) 2 mg vial kit and pre-filled syringe for intravitreal injection is indicated to improve and maintain visual acuity in patients with neovascular age-related macular degeneration (nAMD). In addition, the FDA provisionally determined Enzeevu™ would be interchangeable with the reference medicine, as it is currently subject to an unexpired exclusivity for the first interchangeable biosimilar products.
nAMD, also known as wet AMD, is a subtype of age-related macular degeneration (AMD), which is a leading cause of vision impairment in patients 50 years of age or older in North America.
The active ingredient in Enzeevu™ is aflibercept. Aflibercept is a recombinant fusion protein that binds to vascular endothelial growth factor A (VEGF-A) and placental growth factor (PlGF), inhibiting abnormal vessel growth. In patients with neovascular age-related macular degeneration (nAMD), aflibercept is injected into the eye to improve visual acuity and inhibit disease progression.
