Sandoz Secures Patent Settlement with Regeneron, Clears Path for Aflibercept Biosimilar Launch by End of 2026
核心洞察
Sandoz reached a patent settlement agreement with Regeneron resolving all litigation related to its FDA-approved aflibercept biosimilar Enzeevu (搜索), clearing the path for US market entry by the fourth quarter of 2026.
The agreement concludes vigorous patent disputes involving up to 46 patents protecting Eylea, with Regeneron initially filing infringement proceedings in August 2024 under the Biologics Price Competition and Innovation Act.
Enzeevu (搜索) received FDA approval on August 12, 2024, for treating neovascular age-related macular degeneration (搜索) and was provisionally determined to be interchangeable with the reference medicine Eylea.
Sandoz has successfully resolved all patent litigation with Regeneron Pharmaceuticals related to its aflibercept biosimilar, securing a clear pathway to launch Enzeevu (搜索) by the end of 2026. The settlement agreement announced on September 9, 2025, concludes months of vigorous legal defense against patent infringement claims and positions Sandoz to enter the competitive ophthalmology market with an affordable alternative to Eylea.
Patent Dispute Resolution Enables Market Entry
The agreement resolves patent infringement proceedings initially filed by Regeneron in the US Federal District Court for the District of New Jersey in August 2024, pursuant to the Biologics Price Competition and Innovation Act (BPCIA). Regeneron had claimed that Sandoz infringed up to 46 patents expiring as late as 2040, protecting the reference medicine Eylea.
Under the terms of the settlement, Sandoz may enter the US market with its biosimilar version of Eylea in the fourth quarter of 2026, or earlier under certain circumstances. This timeline provides Sandoz with a defined market entry date while allowing Regeneron to maintain patent protection for a specified period.
FDA-Approved Biosimilar Ready for Launch
Sandoz received FDA approval for Enzeevu (搜索) (aflibercept-abzv) on August 12, 2024. The biosimilar has the same dosage form, route of administration, and presentation as the reference medicine. Notably, the FDA provisionally determined that Enzeevu would be interchangeable with the reference medicine, though it remains subject to an unexpired exclusivity period for the first interchangeable biosimilar products.
Enzeevu (搜索) is indicated to improve and maintain visual acuity in patients with neovascular age-related macular degeneration (搜索) (nAMD). The active ingredient, aflibercept, is a recombinant fusion protein that binds to vascular endothelial growth factor A (VEGF-A (搜索)) and placental growth factor (PlGF (搜索)), inhibiting abnormal vessel growth when injected into the eye.
Addressing Significant Unmet Medical Need
Neovascular AMD, also known as wet AMD (搜索), represents a subtype of age-related macular degeneration (搜索) that is a leading cause of vision impairment in patients 50 years of age or older in North America. The introduction of a biosimilar aflibercept option aims to improve patient access to this critical treatment through increased competition and potentially lower costs.
The most common adverse reactions reported in patients receiving aflibercept include conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure. The treatment carries warnings for potential serious complications including endophthalmitis, retinal detachments, and retinal vasculitis.
Strategic Portfolio Expansion
The anticipated launch of Enzeevu (搜索) further strengthens Sandoz's leadership position in ophthalmology within the US market and expands its biosimilar portfolio. This development advances the company's growth strategy and aligns with Sandoz's stated purpose of pioneering access for patients by providing affordable, high-quality medicines.
Sandoz, which recorded net sales of USD 10.4 billion in 2024, operates as the global leader in generic and biosimilar medicines. The company's portfolio of approximately 1,300 products serves 900 million patient treatments globally, with more than 20,000 employees across 100 nationalities working to generate substantial healthcare savings and social impact.