Sandoz, announced that the European Commission (EC) has granted marketing authorization for Afqlir (aflibercept) 2 mg vial kit and pre-filled syringe for intravitreal injection, a biosimilar to reference medicine Eylea]

Sandoz宣布，欧盟委员会（EC）已批准Afqlir（aflibercept）2 mg小瓶试剂盒和玻璃体内注射用预填充注射器的上市许可，这是一种参考药物Eylea的生物仿制药]

Afqlir is indicated to treat various retinal diseases, including neovascular age-related macular degeneration (nAMD), aiming to prevent disease-related blindness.

Afqlir用于治疗各种视网膜疾病，包括新生血管性年龄相关性黄斑变性（nAMD），旨在预防与疾病相关的失明。

Afqlir is one of several biosimilar value drivers for Sandoz and this approval represents a major step in advancing the company’s growth strategy. Launch is expected as of Q4 2025.

Afqlir是Sandoz的几个生物仿制药价值驱动因素之一，这一批准代表了推进公司增长战略的重要一步。预计将于2025年第四季度推出。

Claire D’Abreu-Hayling, Chief Scientific Officer, Sandoz, 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.

Sandoz首席科学官Claire D'Abreu-Hayling说：“视力下降会严重影响日常活动，从工作到社交互动。早期和扩大获得有效治疗的机会对于患者维持和提高视力至关重要。Afqlir的批准是为欧洲受nAMD等疾病影响的患者提供负担得起且有效的治疗选择的关键时刻。

This milestone underscores our commitment to improving patient outcomes through accessible, high-quality biosimilars.'.

这一里程碑强调了我们通过可获得的高质量生物仿制药改善患者预后的承诺。”。

nAMD is a subtype of AMD, characterized by a vision loss in the central zone, and is a leading cause of vision impairment in patients over 65 years of age. nAMD accounts for approximately 10 to 20% of all AMD cases, but is responsible for 90% of the severe vision loss due to AMD.  A study found that the prevalence of nAMD in France, Germany, Italy, Spain, the UK, the US and Japan is around 3.6 million patients, of which 2.5 million are diagnosed and only 1.7 million receive treatment..

nAMD是AMD的一种亚型，其特征是中央区域视力丧失，是65岁以上患者视力障碍的主要原因。nAMD约占所有AMD病例的10%至20%，但占AMD导致的严重视力丧失的90%。一项研究发现，法国、德国、意大利、西班牙、英国、美国和日本的nAMD患病率约为360万，其中250万被诊断出，只有170万人接受治疗。。