European Commission Approves Sandoz's Aflibercept Biosimilar, Afqlir, for Retinal Diseases
Key Insights
The European Commission has granted marketing authorization to Sandoz Group's Afqlir (aflibercept) biosimilar, a 2 mg vial kit and pre-filled syringe for intravitreal injection.
Afqlir is approved for treating retinal diseases, including neovascular age-related macular degeneration (search) (nAMD), offering a more affordable alternative to the reference aflibercept (Eylea).
Sandoz anticipates launching Afqlir in Europe starting in Q4 2025, potentially improving access to effective treatments for patients with vision loss.
The European Commission (EC) has granted marketing authorization to Afqlir (aflibercept), a biosimilar developed by Sandoz Group referencing Bayer AG's Eylea (aflibercept). This approval paves the way for a more accessible treatment option for retinal diseases, including neovascular age-related macular degeneration (search) (nAMD). The biosimilar is formulated as a 2 mg vial kit and pre-filled syringe designed for intravitreal injection.
Clinical Significance
The approval of Afqlir marks a significant step towards providing cost-effective alternatives for patients suffering from vision-threatening conditions. Neovascular AMD, a leading cause of vision loss in the elderly, necessitates timely and effective intervention to preserve visual acuity. With Afqlir, Sandoz aims to address the unmet need for affordable treatment options in Europe.
Sandoz's Perspective
Claire D’Abreu-Hayling, Chief Scientific Officer for Sandoz, emphasized the importance of early access to effective treatments for maintaining and improving visual acuity. "Vision loss significantly affects daily activities, from work to social interactions. 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."
Anticipated Launch
Sandoz anticipates launching Afqlir in Europe starting in Q4 2025. This launch is expected to expand treatment access and potentially reduce the economic burden associated with managing retinal diseases like nAMD.