Sandoz has announced that the European Commission (EC) has granted marketing authorization for Afqlir (aflibercept) 2 mg vial kit and pre-filled syringe for intravitreal injection. This biosimilar to Eylea is set to provide a more accessible treatment option for retinal diseases, including neovascular age-related macular degeneration (nAMD), a leading cause of blindness.
Afqlir is poised to be a significant asset in Sandoz's portfolio, with its market launch anticipated in Q4 2025. The biosimilar contains aflibercept, a recombinant fusion protein that targets vascular endothelial growth factor A (VEGF-A) and placental growth factor (PlGF), effectively inhibiting abnormal blood vessel growth in the eye. It is administered via intravitreal injection to improve vision and slow disease progression.
Clinical Evidence and Development
The approval of Afqlir was underpinned by a comprehensive biosimilar program, which included analytical, preclinical, and clinical data derived from the Mylight study. This rigorous evaluation confirmed that Afqlir demonstrates equivalent efficacy and comparable safety profiles to its reference medicine, Eylea.
Claire D’Abreu-Hayling, Sandoz chief scientific officer, emphasized the importance of early access to effective treatments for vision loss. "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," she stated. "This milestone underscores our commitment to improving patient outcomes through accessible, high-quality biosimilars."
Therapeutic Indications
Afqlir is approved to improve and maintain visual acuity in patients with nAMD, macular oedema from retinal vein occlusion (RVO), diabetic macular oedema (DME), and myopic choroidal neovascularisation (mCNV).
Competitive Landscape
Eylea, the reference medicine, was jointly developed by Regeneron and Bayer. Other notable developments in the aflibercept biosimilar space include Biocon Biologics' Yesafili, which received EC marketing authorization in September 2023, and Altos Biologics' ALT-L9, which is currently under review by the EMA. Afqlir was also approved in the US as Enzeevu in August of this year for the treatment of nAMD.
