Sandoz the global leader in generic and biosimilar medicines, today announced that the European Commission (EC) has granted marketing authorization for Afqlir® (aflibercept) 2 mg vial kit and pre-filled syringe for intravitreal injection, a biosimilar to reference medicine Eylea®. Afqlir® is indicated to treat various retinal diseases, including neovascular age-related macular degeneration (nAMD), aiming to prevent disease-related blindness.
Afqlir® is one of several biosimilar value drivers for Sandoz and this approval represents a major step in advancing the company’s growth strategy. Launch is expected as of Q4 2025.
Claire D’Abreu-Hayling, Chief Scientific Officer, Sandoz, said: "Vision loss significantly affects daily activities, from work to social interactions. Early and expanded access to effective treatments is essential for patients to maintain and improve their visual acuity. The approval of Afqlir® is a pivotal moment in delivering an affordable and effective treatment option to patients in Europe who are affected by conditions such as nAMD. This milestone underscores our commitment to improving patient outcomes through accessible, high-quality biosimilars."
nAMD is a subtype of AMD, characterized by a vision loss in the central zone, and is a leading cause of vision impairment in patients over 65 years of age. nAMD accounts for approximately 10 to 20% of all AMD cases, but is responsible for 90% of the severe vision loss due to AMD. A study found that the prevalence of nAMD in France, Germany, Italy, Spain, the UK, the US and Japan is around 3.6 million patients, of which 2.5 million are diagnosed and only 1.7 million receive treatment. Eylea® is a registered trademark of Bayer AG.
The active ingredient in Afqlir® 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. Aflibercept is injected into the eye to improve visual acuity and inhibit 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 neovascular age-related macular degeneration (nAMD), macular oedema following retinal vein occlusion (RVO), diabetic macular oedema (DME) and myopic choroidal neovascularisation (mCNV).
