European Commission Approves Sandoz's Afqlir® (aflibercept) Biosimilar for Retinal Diseases
核心洞察
Sandoz's Afqlir® (aflibercept) receives European Commission approval as a biosimilar to Eylea® for treating retinal diseases, including neovascular age-related macular degeneration (搜索) (nAMD).
Afqlir® offers a more affordable treatment option, potentially improving access for patients in Europe affected by vision loss due to conditions like nAMD.
Clinical data confirmed Afqlir® has equivalent efficacy and comparable safety to its reference medicine, marking a significant step in Sandoz's growth strategy.
The European Commission (EC) has granted marketing authorization for Sandoz's Afqlir® (aflibercept) as a biosimilar to Eylea® (aflibercept). This approval paves the way for a more affordable treatment option for various retinal diseases, including neovascular age-related macular degeneration (搜索) (nAMD), a leading cause of vision impairment in individuals over 65.
Afqlir® is available in 2 mg vial kit and pre-filled syringe for intravitreal injection. Sandoz anticipates launching the product in Q4 2025.
Clinical Significance
nAMD accounts for a significant portion of severe vision loss related to age-related macular degeneration (AMD). While it represents only 10-20% of all AMD cases, it is responsible for 90% of the severe vision loss attributed to AMD. A study across France, Germany, Italy, Spain, the UK, the US, and Japan estimated approximately 3.6 million patients with nAMD, with only 1.7 million receiving treatment.
Claire D’Abreu-Hayling, Chief Scientific Officer at Sandoz, emphasized the importance of early access to effective treatments for maintaining 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," she stated.
Mechanism of Action and Clinical Data
The active ingredient in Afqlir® is aflibercept, a recombinant fusion protein that binds to vascular endothelial growth factor A (搜索) (VEGF-A (搜索)) and placental growth factor (搜索) (PlGF (搜索)), 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 studies, as well as clinical data from the Mylight study. The data confirmed equivalent efficacy and comparable safety profiles between Afqlir® and its reference medicine, Eylea®.
Indications
Afqlir® is indicated for improving and maintaining visual acuity in patients with:
- Neovascular age-related macular degeneration (nAMD)
- Macular oedema following retinal vein occlusion (RVO)
- Diabetic macular oedema (DME)
- Myopic choroidal neovascularisation (mCNV)