European Commission Approves Sandoz's Afqlir, an Aflibercept Biosimilar, for Retinal Diseases
Key Insights
Sandoz's Afqlir (aflibercept) has received European Commission approval for treating retinal diseases, including neovascular age-related macular degeneration (search) (nAMD).
Afqlir, a biosimilar to Eylea, offers an affordable treatment option, potentially improving access for patients with vision impairment in Europe.
Launch of Afqlir is anticipated in Q4 2025, marking a significant step in Sandoz's growth strategy and commitment to biosimilar medicines.
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, as announced by Sandoz. This approval allows Afqlir to be used in the treatment of various retinal diseases, including neovascular age-related macular degeneration (search) (nAMD), with the goal of preventing disease-related blindness.
Afqlir is a biosimilar of aflibercept, indicated for conditions including neovascular age-related macular degeneration (search) (nAMD), macular oedema (search) following retinal vein occlusion (RVO), diabetic macular oedema (search) (DME) and myopic choroidal neovascularisation (search) (mCNV).
Clinical Significance
According to Sandoz, the approval of Afqlir is a pivotal moment in delivering an affordable and effective treatment option to patients in Europe affected by conditions such as nAMD. Claire D’Abreu-Hayling, Chief Scientific Officer at Sandoz, emphasized that early and expanded access to effective treatments is essential for patients to maintain and improve their visual acuity.
nAMD, a leading cause of vision impairment in patients over 65, accounts for 10-20% of all AMD cases but is responsible for 90% of the severe vision loss due to AMD. A 2020 study estimated that approximately 3.6 million patients in France, Germany, Italy, Spain, the UK, the US, and Japan have nAMD, with only 1.7 million receiving treatment.
About Aflibercept
Aflibercept is a recombinant fusion protein that binds to vascular endothelial growth factor A (VEGF-A (search)) and placental growth factor (PlGF (search)), inhibiting abnormal vessel growth. It is administered via intravitreal injection to improve visual acuity and inhibit disease progression. The biosimilar development program for Afqlir included analytical and preclinical in vitro study data, as well as clinical data from the Mylight study, which confirmed equivalent efficacy and comparable safety to its reference medicine.
Sandoz anticipates launching Afqlir in Q4 2025. This approval is considered a major step in advancing the company’s growth strategy, reinforcing its global and European leadership in biosimilar medicines.