Cost-Effective Solution for Retinal Diseases Enters European Market
Sandoz Introduces Aflibercept Biosimilar to Support Patients and Healthcare Sustainability
On November 24, 2025, in Basel, Sandoz, a global leader in affordable medicines, announced the European launch of Afqlir® (aflibercept). The product is a biosimilar presented as a 2 mg vial kit and pre-filled syringe for intravitreal injection.
Afqlir® received approval from the European Commission in November 2024 for the treatment of various retinal diseases in adult patients, with the aim of preventing disease-related blindness. Studies have confirmed that the product demonstrates equivalent efficacy, safety, and pharmacokinetics when compared to the reference medicine.
Aflibercept is considered a gold standard treatment for several neovascular retinal conditions. Diseases such as neovascular age-related macular degeneration (nAMD), retinal vein occlusion (RVO), and diabetic macular edema (DME) are leading causes of vision loss, and their global prevalence is rising.
Sandoz’s Europe President commented that vision loss severely impacts patients and their caregivers, while the current high cost of treatments for neovascular retinal diseases places a further burden on healthcare systems. Therefore, the launch of Afqlir® is a key milestone, providing a high-quality, affordable aflibercept option for European patients that helps maintain and improve vision, while promoting more sustainable care across the region.
Neovascular age-related macular degeneration (nAMD) is characterized by central vision loss and is a major cause of visual impairment in patients over 65 years old. Although nAMD accounts for only about 10% to 20% of all AMD cases, it is responsible for 90% of severe vision loss linked to the condition. It is estimated that approximately 4.0 million people in seven major countries (France, Germany, Italy, Spain, UK, US, and Japan) have nAMD, but only 2.0 million receive treatment.
Afqlir® will be rolled out across Europe, beginning in the UK, followed by other large markets such as Germany and France, with further launches slated for 2026.
This product is one of several biosimilar growth drivers for Sandoz. The Afqlir® launch solidifies the company’s leadership in biosimilars, which dates back to its first introduction in 2006. This move also expands Sandoz’s presence in the anti-vascular endothelial growth factor (anti-VEGF) ophthalmology market, valued at approximately USD 15 billion.
Sandoz is committed to sustainably and affordably helping millions of patients access critical and potentially life-changing biologic medicines, with a leading global portfolio comprising 13 approved biosimilars and 27 additional assets in development.
The company also reached a settlement agreement resolving all patent disputes with a major pharmaceutical company related to its US Food and Drug Administration (FDA)-approved aflibercept biosimilar. This agreement clears the way for the US launch of Enzeevuâ„¢ (aflibercept-abzv) by the end of 2026.
About Afqlir® (aflibercept): Aflibercept is a recombinant fusion protein that binds to vascular endothelial growth factors (VEGF-A, VEGF-B) and placental growth factor (PlGF), thereby inhibiting abnormal vessel growth. It is injected into the eye to improve visual acuity and slow disease progression. The robust biosimilar development program for Afqlir®, which included analytical and preclinical data, as well as clinical data from the Phase 3 Mylight study, confirmed equivalent efficacy and comparable safety to the reference medicine.
