Sandoz's Afqlir (Aflibercept) Biosimilar Approved in Europe for Retinal Diseases
核心洞察
Sandoz has received European Commission approval for Afqlir, an aflibercept biosimilar, to treat retinal diseases including neovascular age-related macular degeneration (搜索) (nAMD (搜索)).
Afqlir, expected to launch in Q4 2025, will be available as a 2 mg vial kit and pre-filled syringe for intravitreal injection.
nAMD (搜索) accounts for 90% of severe vision loss in AMD cases, affecting a significant patient population across major markets.
Sandoz has secured European Commission approval for Afqlir (aflibercept), a biosimilar to Eylea, marking a significant advancement in the treatment of retinal diseases. This approval paves the way for a Q4 2025 launch of Afqlir as a 2 mg vial kit and pre-filled syringe, administered via intravitreal injection.
Addressing nAMD and Vision Loss
Neovascular age-related macular degeneration (搜索) (nAMD (搜索)) is a leading cause of vision impairment, particularly among individuals over 65. While nAMD represents only 10-20% of all AMD cases, it accounts for 90% of severe vision loss associated with AMD. The availability of Afqlir offers a crucial treatment option for this patient population.
According to a study, among 3.6 million patients with nAMD (搜索) across major markets, 2.5 million are diagnosed, but only 1.7 million receive treatment. This highlights a significant unmet need that Afqlir aims to address by increasing access to effective and affordable treatments.
Sandoz's Commitment to Biosimilars
Claire D’Abreu-Hayling, Chief Scientific Officer at Sandoz, emphasized the impact of vision loss on daily life and the importance of early access to effective treatments. "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 (搜索)," she stated. "This milestone underscores our commitment to improving patient outcomes through accessible, high-quality biosimilars."
Mechanism of Action and Clinical Data
The active ingredient in Afqlir is aflibercept, a recombinant fusion protein that inhibits abnormal vessel growth by binding to vascular endothelial growth factor A (VEGF-A (搜索)) and placental growth factor (搜索) (PlGF (搜索)). This mechanism helps improve visual acuity and inhibit disease progression when injected into the eye.
The approval of Afqlir was supported by a comprehensive biosimilar development program, including analytical, preclinical in vitro studies, and clinical data from the Mylight study. These studies confirmed that Afqlir demonstrates equivalent efficacy and comparable safety to its reference medicine, Eylea.
Indications
Afqlir is indicated for improving and maintaining visual acuity in patients with several conditions, including neovascular age-related macular degeneration (搜索) (nAMD (搜索)), macular oedema (搜索) following retinal vein occlusion (搜索) (RVO (搜索)), diabetic macular oedema (搜索) (DME (搜索)), and myopic choroidal neovascularisation (搜索) (mCNV (搜索)).