The European Commission (EC) has granted marketing authorisation for Sandoz's Afqlir, a biosimilar to the reference medicine Eylea, a registered trademark of Bayer, to treat retinal diseases.
The approval boosts the company's biosimilar portfolio.
Afqlir's 2mg vial kit and pre-filled syringe for intravitreal injection will combat blindness associated with neovascular age-related macular degeneration (nAMD) and other conditions.
The active component, aflibercept, is a recombinant fusion protein that targets and inhibits placental growth factor and vascular endothelial growth factor A, preventing abnormal vessel growth.
Administered via intravitreal injection, aflibercept aims to improve visual acuity and halt the progression of the disease. Afqlir’s launch is anticipated to commence in the fourth quarter of 2025.
Its comprehensive biosimilar development programme included analytical and preclinical in vitro study data and clinical data from the Mylight trial.
This programme confirmed that Afqlir has equivalent efficacy as well as comparable safety to Eylea.
Afqlir is indicated not only for nAMD but also for macular oedema following retinal vein occlusion, myopic choroidal neovascularisation and diabetic macular oedema.
Sandoz chief scientific officer Claire D’Abreu-Hayling 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 major cause of vision impairment in individuals aged above 65 years, responsible for 90% of severe vision loss due to AMD, despite representing only 10 to 20% of all AMD cases.
In August 2024, the US Food and Drug Administration (FDA) approved Sandoz’s Enzeevu (aflibercept-abzv), the biosimilar for wet AMD.
