Sandoz Advances Biosimilar Leadership with EU Introduction of Afqlir for Vision-Saving Retinal Conditions

Sandoz Advances Biosimilar Leadership with EU Introduction of Afqlir for Vision-Saving Retinal Conditions

(IN BRIEF) Sandoz has launched Afqlir®, its biosimilar to aflibercept, across Europe following European Commission approval in 2024. Equivalent in efficacy, safety, and pharmacokinetics to Eylea®, Afqlir® provides a lower-cost treatment option for serious retinal diseases such as nAMD, RVO, DME, and mCNV. The launch supports Sandoz’s broader growth strategy in the USD 15 billion anti-VEGF market and builds on a series of recent biosimilar milestones. Beginning in the UK and expanding to major European markets in 2026, Afqlir® reinforces the company’s long-standing commitment to increasing patient access to key biologic therapies. Rising global prevalence of retinal diseases and limited access to treatment underscore the significance of this introduction for patients and healthcare systems alike.

(PRESS RELEASE) BASEL, 24-Nov-2025 — /EuropaWire/ — Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in affordable medicines, has officially launched Afqlir® (aflibercept) across Europe, marking a major milestone in its biosimilar expansion strategy and strengthening its position in the fast-growing anti-VEGF ophthalmology market valued at approximately USD 15 billion. The European Commission approved Afqlir® in November 2024, authorizing its use for the same indications as the reference product Eylea®, including several neovascular retinal diseases that can lead to severe vision impairment or blindness. Clinical studies have confirmed that Afqlir® matches its reference medicine in efficacy, safety, and pharmacokinetics.

Aflibercept is widely regarded as a gold-standard treatment for conditions such as neovascular age-related macular degeneration (nAMD), retinal vein occlusion (RVO), diabetic macular edema (DME), and other serious retinal diseases. With global prevalence rising, these conditions represent a growing burden on both patients and healthcare systems. Sandoz’s introduction of an affordable aflibercept biosimilar is intended to improve patient access while supporting more sustainable ophthalmic care across Europe.

“Vision loss can devastate lives, affecting not only those living with conditions like nAMD but also their families and caregivers,” said Christophe Delenta, President Europe at Sandoz. “At the same time, the high cost of current treatments places considerable strain on healthcare systems. The launch of Afqlir® is an important milestone—bringing a high-quality and affordable aflibercept option that maintains and improves vision, while contributing to more sustainable care throughout the region.”

Neovascular AMD remains one of the leading causes of vision loss in adults over 65, accounting for up to 90% of severe AMD-related visual impairment despite representing only a minority of overall AMD cases. Across major global markets—including France, Germany, Italy, Spain, the UK, the United States, and Japan—an estimated four million people are affected by nAMD. Yet only about two million receive treatment, underscoring the urgent need for accessible therapeutic options.

The rollout of Afqlir® begins today in the UK and will extend to major European markets including Germany and France, with broader launches planned for 2026. The product will be available both as a 2 mg vial kit and a pre-filled syringe for intravitreal injection.

Afqlir® is one of several key biosimilar growth drivers for Sandoz. This launch follows recent biosimilar milestones such as the US introduction of Tyruko® (natalizumab) and the anticipated European launch of biosimilar denosumab in December 2025. By continuing to expand its leadership in biosimilars, Sandoz remains committed to enabling millions of patients worldwide to access critical, potentially life-changing biologic medicines affordably and sustainably. The company now offers a global portfolio of 13 biosimilars, with 27 additional assets in various stages of development.

The launch further builds on the company’s longstanding legacy in biosimilars dating back to 2006 and expands its presence in the competitive anti-VEGF market. In parallel, Sandoz recently resolved all US patent disputes with Regeneron regarding its FDA-approved aflibercept biosimilar, paving the way for the US launch of Enzeevu™ (aflibercept-abzv) by late 2026.

About Afqlir® (aflibercept)

Afqlir® (aflibercept) is a recombinant fusion protein that binds to vascular endothelial growth factor A (VEGF-A), VEGF-B, and placental growth factor (PlGF), inhibiting abnormal vessel growth. Aflibercept is injected into the eye to improve visual acuity and slow down disease progression. The robust biosimilar development program of Afqlir® consisted of a comprehensive package including analytical and preclinical in vitro study data, as well as clinical data from the Mylight study, and confirmed that Afqlir® has equivalent efficacy and comparable safety to its reference medicine.

Afqlir® is indicated to improve and maintain visual acuity in patients with nAMD, macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and myopic choroidal neovascularization (mCNV)¹.

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.

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¹¹ Galindo-Camacho RM, Blanco-Llamero C, da Ana R, Fuertes MA, Señoráns FJ, Silva AM, García ML, Souto EB. Therapeutic Approaches for Age-Related Macular Degeneration. Int J Mol Sci. 2022 Oct 4;23 (19):11769. doi: 10.3390/ijms231911769. PMID: 36233066; PMCID: PMC9570118 [Last accessed November 2025].

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ABOUT SANDOZ

Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in affordable 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.

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SOURCE: Sandoz