Sandoz launches Afqlir® (aflibercept) in Europe, providing affordable treatment option for patients with retinal diseases

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

• Afqlir^® approved by European Commission in November 2024; matches reference medicine in efficacy, safety and pharmacokinetics
• Gold standard treatment* for patients living with various retinal diseases such as neovascular age-related macular degeneration (nAMD)
• Another milestone in Sandoz growth strategy, building on recent biosimilar launches including Tyruko^® (natalizumab) in US on November 17; European launch of denosumab expected December 2025
• Reinforces Sandoz commitment to helping patients access critical and potentially life-changing biologic medicines through leading global portfolio of 13 biosimilars
• Launch expands Sandoz growing presence in ~USD 15 billion anti-VEGF** market

Basel, November 24, 2025 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in affordable medicines, today announced the European launch of Afqlir^® (aflibercept). Afqlir^®, a 2 mg vial kit and pre-filled syringe for intravitreal injection, was approved by the European Commission in November 2024 for the same indications in adult patients as the reference medicine, Eylea^®***, namely the treatment of various retinal diseases to prevent disease-related blindness^1,2. Studies confirm that Afqlir^® matches the reference medicine in efficacy, safety and pharmacokinetics³.

Aflibercept is considered a Gold standard⁴ for treating various neovascular retinal diseases. Conditions like age-related macular degeneration (AMD), retinal vein occlusion (RVO) and diabetic macular edema (DME) are leading causes of vision loss and their global prevalence is increasing^5-10.

Christophe Delenta, President Europe, Sandoz, said: “Vision loss can devastate lives, affecting not only those living with conditions like nAMD but also the families and caregivers who support them. At the same time, the high cost of current treatments for neovascular retinal diseases places further strain on healthcare systems. That’s why the launch of Afqlir^® is such an important milestone: It brings a high-quality, affordable aflibercept option for European patients that maintains and improves vision, while also supporting more sustainable care across the region.”

A subtype of age-related macular degeneration (AMD), nAMD is characterized by vision loss in the central zone and is a leading cause of vision impairment in patients over 65 years of age¹¹. Although nAMD represents about 10 to 20 percent of all AMD cases, it accounts for 90 percent of severe vision loss linked to AMD¹². In France, Germany, Italy, Spain, the UK, the US and Japan, around 4.0 million people are estimated to have nAMD. Of these, 2.8 million are diagnosed but only 2.0 million receive treatment¹³.

Afqlir^® will be launched across Europe, beginning in the UK today, followed by other major markets such as Germany and France, with additional rollouts to follow in 2026.

Afqlir^® is one of several biosimilar value drivers for Sandoz and this launch represents another step in advancing the company’s growth strategy, building on major launches this year including Tyruko^® (natalizumab) and Wyost^® (denosumab) and Jubbonti^® (denosumab) in the US.

Sandoz is committed to helping millions of patients access critical and potentially life-changing biologic medicines sustainably and affordably, with a leading global portfolio comprising 13 biosimilars and a further 27 assets in various stages of development.

The launch builds on the existing Sandoz leadership and legacy in biosimilars, dating back to the introduction of the first biosimilar in 2006, and expands the company’s presence in the ~USD 15 billion anti-VEGF ophthalmology market¹⁴.

In September 2025, Sandoz also announced that it had 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 aflibercept biosimilar, clearing the path for the launch of Enzeevu™ (aflibercept-abzv) in the US by the end of 2026.

* Gold standard refers to an established and widely used treatment option for a certain disease.

** Anti-vascular endothelial growth factor.

*** Eylea^® is a registered trademark of Bayer AG.

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.

REFERENCES

¹ European Medicines Agency (EMA). Afqlir (aflibercept): Prescribing Information. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/afqlir [Last accessed November 2025].

² European Medicines Agency (EMA). Eylea (aflibercept): Prescribing Information. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/eylea [Last accessed November 2025].

³ Bordon, A; Kaiser, Peter K; Wolf, A; Cen,L; Heyn, J; Urosevic, D; Dodeller, F; Allmannsberger,L; Silva, R. Efficacy and safety of the proposed biosimilar aflibercept, SDZ-AFL, in patients with neovascular age-related macular degeneration: 52-Week Results From the Phase 3 Mylight Study. Retina 44(10):p 1704-1713, October 2024. | DOI: 10.1097/IAE.0000000000004174 [Last accessed November 2025].

⁴ Adams BS, et al. Aflibercept. 2023 Jul 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan [Last accessed November 2025].

⁵ Deng Y, et al. Age-related macular degeneration: Epidemiology, genetics, pathophysiology, diagnosis, and targeted therapy. Genes Dis. 2021; 9(1): 62–79 [Last accessed November 2025].

⁶ Wong WL, et al. Lancet Glob Health 2014; 2(2): e106–116 [Last accessed November 2025].

⁷ Morris B, et al. Postgrad Med J. 2007; 83(979): 301–307 [Last accessed November 2025].

⁸ Song P, et al. J Glob Health. 2019; 9(1): 010427 [Last accessed November 2025].

⁹ Yau JW, et al. Diabetes Care. 2012;35(3): 556–564 [Last accessed November 2025].

¹⁰ Im JHB, et al. Surv Ophthalmol. 2022;67(4): 1244–1251 [Last accessed November 2025].

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].

¹² Quillen DA. Am Fam Physician. 1999;60(1):99-108 [Last accessed November 2025].

¹³ DRG Clarivate Landscape & Forecast. Dry and Wet Age-Related Macular Degeneration. December 2024 [Last accessed November 2025].

¹⁴ Industry Analyst Report. Jefferies: Aug-2025. Data on file.

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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