林业发展局批准了Celltrion的EYDENZELT,这是与EYLEA类似的生物,用于治疗多种眼病,扩大治疗范围。 The FDA approved Celltrion’s EYDENZELT, a biosimilar to EYLEA, for treating multiple eye conditions, expanding treatment access.

美国食品和药物管理局已经批准了Celltrion的EYDENZELT(Afliberty-boav),该生物与EYLEA相似,用于治疗与年龄有关的湿性肌肉畸形、糖尿病的血管水肿、因视网膜静脉隔绝产生的肌肉水肿以及糖尿病的视网膜病理病。 The U.S. FDA has approved Celltrion’s EYDENZELT (aflibercept-boav), a biosimilar to EYLEA, for treating wet age-related macular degeneration, diabetic macular edema, macular edema from retinal vein occlusion, and diabetic retinopathy. 这一批准基于临床和分析数据,其中包括对348名DME病人进行的第三阶段试验,证实EDENZELT具有与EYLEA相同的功效、安全和药用动力学。 The approval, based on clinical and analytical data including a phase III trial with 348 DME patients, confirms EYDENZELT’s equivalent efficacy, safety, and pharmacokinetics to EYLEA. 它可以作为一种注射和预先填充的注射器,作为Celltrion的第一个经林业发展局批准的眼科产品,并在95亿美元的市场上扩大治疗机会。 It is available as an injection and prefilled syringe, marking Celltrion’s first FDA-approved ophthalmology product and expanding treatment access in a $9.5 billion market. 该药物以前在欧洲和澳大利亚得到批准,其细胞群的目标是到2030年将22种生物类似物质商业化。 The drug was previously approved in Europe and Australia, with Celltrion aiming to commercialize 22 biosimilars by 2030.