FDA批准眼科药Lucamzi为Lucentis生物类似药：582名湿性黄斑变性患者研究支持，计划2027年在美国上市
美国食品药品监管局（FDA）已批准眼科药物 Lucamzi（ranibizumab-blrz）作为 Lucentis 的生物类似药，用于治疗新生血管性（湿性）年龄相关性黄斑变性及其他严重眼病。开发商 Xbrane Biopharma 10月29日在瑞典 Solna 公布了这一批准，公司正与合作伙伴敲定该药2027年在美国上市的准备工作。
据公司公告，FDA 对生物类似药的审评基于申报方提交的全部证据，以确保医疗提供者与患者对其安全性、有效性与质量有信心。Lucamzi 的证据包括结构与功能层面的全面对比分析评估，以及一项纳入582名湿性黄斑变性患者的3期临床研究，该研究显示其疗效与原研药等效、安全性相当。
Xbrane 首席执行官 Martin Åmark 表示，FDA 批准 Lucamzi 是公司的里程碑事件，为惠及更多患者、实现研发投资回报提供了关键机会。
Ranibizumab 是一种抗血管内皮生长因子（抗 VEGF）药物，用于治疗视网膜血管疾病，这类疾病是全球致盲的主要原因之一。公司引述的数据显示，美国约有2,000万人患有年龄相关性黄斑变性，晚期患者的年度经济负担估计达494亿美元；生物类似药竞争增加可提供更具成本效益的等效治疗选择，有助于降低美国医疗成本、改善患者可及性。
FDA Approves Lucamzi as a Biosimilar to Lucentis, Backed by a 582-Patient Wet AMD Study; U.S. Launch Planned for 2027
The U.S. Food and Drug Administration (FDA) has approved Lucamzi (ranibizumab-blrz) as a biosimilar to Lucentis for the treatment of neovascular (wet) age-related macular degeneration (AMD) and other serious eye conditions. Developer Xbrane Biopharma announced the approval on October 29 in Solna, Sweden, and said it is finalizing preparations, together with its partners, for a U.S. launch during 2027.
According to the company, the FDA rigorously reviews biosimilars based on the totality of the evidence presented by the sponsor, so that healthcare providers and patients can be confident of their safety, effectiveness and quality. For Lucamzi, that evidence included a comprehensive comparative analytical assessment at a structural and functional level, as well as a Phase 3 clinical study in 582 patients with wet AMD that demonstrated equivalent efficacy and comparable safety to the reference product.
"FDA approval of Lucamzi is a landmark event for Xbrane, representing a key opportunity to reach many more patients and to realize a return on our development investments," said Martin Åmark, CEO of Xbrane Biopharma.
Ranibizumab is an anti-VEGF (vascular endothelial growth factor) drug for treating retinal vascular disorders, a leading cause of blindness globally. Around 20 million people in the United States are living with AMD, and the total economic burden of late-stage AMD in the U.S. is estimated at $49.4 billion annually, the company said. Increased biosimilar competition on ranibizumab provides cost-effective options to deliver equivalent therapy at lower prices, reducing U.S. healthcare costs and improving patient access.
来源：GSM·美国（原文链接）
图片来源：图：医务人员为患者做眼科检查（资料图）。美国海军照片，Photographer's Mate 3rd Class Rebecca J. Moat 摄，公共领域，经 Wikimedia Commons。 / A medical professional conducts an eye examination (file photo). U.S. Navy photo by Photographer's Mate 3rd Class Rebecca J. Moat, public domain, via Wikimedia Commons.
