Sandoz reaches agreement with Regeneron, resolving all patent litigation related to its US aflibercept biosimilar

Ad-hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules

• Agreement clears path for launch of Enzeevu™ (aflibercept-abzv) by end of 2026 
• Enzeevu™ is an FDA-approved Sandoz biosimilar to Eylea^®
• Anticipated launch further strengthens Sandoz biosimilar portfolio, advances growth strategy in US and ensures more patients have access to this affordable medicine

Basel, September 9, 2025 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, today announced that it has reached an agreement with Regeneron Pharmaceuticals, Inc. (Regeneron), 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. 

About Enzeevu™ (aflibercept-abzv)
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).[1] 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.[2]

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.

SELECT IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
Ocular or periocular infection
Active intraocular inflammation
Hypersensitivity

WARNINGS AND PRECAUTIONS
Endophthalmitis, retinal detachments, and retinal vasculitis with or without occlusion may occur following intravitreal injections. Patients and/or caregivers should be instructed to report any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately.

Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection.

There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors.

ADVERSE REACTIONS
The most common adverse reactions (=5%) reported in patients receiving aflibercept were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased.

This is not the complete list of all the safety information for Enzeevu™. Please see full Prescription Info for Enzeevu™. 

REFERENCES
 [1] Enzeevu™. Prescribing Information. Available at:
https://prod.cms.us.sandoz.com/sites/spare37_sandoz_com/files/Media%20Documents/ENZEEVU_PI_2024_2.pdf [Last accessed: August 2025]
[2] American Academy of Ophthalmology^®. Age-related macular degeneration (AMD). Available at:
https://www.aao.org/eye-health/diseases/amd-macular-degeneration [Last accessed: August 2025]

*Eylea^® is a registered trademark of Regeneron Pharmaceuticals, Inc.

DISCLAIMER
This Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly revise any forward-looking statements, except as required by law.

ABOUT SANDOZ
Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 900 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2024, Sandoz recorded net sales of USD 10.4 billion.