Health Canada Approves Aflivu, an Aflibercept Biosimilar for Retinal Diseases

加拿大卫生部批准了用于视网膜疾病的阿非利珠单抗（Aflivu），一种阿柏西普生物类似药。

July 09, 2025

2025年7月9日

Health Canada has approved Aflivu (aflibercept), a biosimilar to Eylea, for the treatment of several serious retinal conditions. These include neovascular age-related macular degeneration (AMD), macular edema secondary to central or branch retinal vein occlusion (RVO), diabetic macular edema (DME), and myopic choroidal neovascularization..

加拿大卫生部已批准Aflivu（阿柏西普），即Eylea的生物类似药，用于治疗多种严重视网膜疾病。这些疾病包括新生血管性年龄相关性黄斑变性（AMD）、中央或分支视网膜静脉阻塞（RVO）继发的黄斑水肿、糖尿病性黄斑水肿（DME）以及近视性脉络膜新生血管化。

Aflivu Marks Apotex’s First Ophthalmic Biosimilar

阿弗利夫标志着阿波特克斯的第一个眼科生物类似药。

According to a press release issued by Apotex, this approval represents the Canadian-based global health company’s first ophthalmic biosimilar and its fourth biosimilar approval since 2016. The growing biosimilar portfolio aligns with Apotex’s strategy to expand its biologics offerings as part of its Journey of Health initiative..

根据Apotex发布的新闻稿，此次批准代表这家加拿大全球健康公司的首款眼科生物类似药，也是自2016年以来其获得的第四款生物类似药批准。不断增长的生物类似药产品组合与Apotex作为其“健康之旅”计划一部分扩展生物制品的战略相一致。

Raymond Shelley, President of Apotex Canada, commented on the significance of this milestone:

加拿大阿普泰克公司总裁雷蒙德·雪莱对这一里程碑的意义发表了评论：

“With Aflivu, we're expanding affordable treatment options for Canadians affected by retinal diseases. Apotex continues to deliver innovative, patient-focused solutions across our growing portfolio of brands, biosimilars, generics and consumer health products.”

“通过Aflivu，我们正在为受视网膜疾病影响的加拿大人扩展可负担的治疗选择。Apotex继续在我们不断增长的品牌、生物类似药、仿制药和消费者健康产品组合中提供创新的、以患者为中心的解决方案。”

Clinical Perspectives on the Importance of Biosimilars

临床视角：生物类似药的重要性

Bernard R. Hurley, BSc, MD, FRCSC, Assistant Professor at the University of Ottawa Eye Institute, underscored the value of biosimilars in ophthalmology:

贝尔纳·R·赫尔利，理学学士、医学博士、加拿大皇家外科医学院院士，渥太华大学眼科研究所助理教授，强调了生物仿制药在眼科领域的价值：

“The approval of Aflivu represents a positive advancement in ophthalmic care. Biosimilars, supported by clinicians, regulators, and manufacturers, have the potential to transform the treatment landscape for retinal diseases, preserving vision and providing quality, cost-effective care for countless Canadians.”.

“阿夫利夫的批准代表了眼科护理方面的积极进展。生物类似药在临床医生、监管机构和制造商的支持下，有潜力改变视网膜疾病的治疗前景，保护视力，并为无数加拿大人提供高质量且经济实惠的护理。”

Ghassan Cordahi, MD, FACS, Assistant Clinical Professor in the Department of Ophthalmology at Université de Montréal, also highlighted the clinical benefits:

蒙特利尔大学眼科系临床助理教授、医学博士、美国外科医师学会会员加桑·科达希也强调了临床益处：

“In clinical practice, having access to a broader range of therapeutic options can empower physicians to tailor care to individual patients' needs. Aflibercept has been a cornerstone in managing retinal diseases, and the introduction of Aflivu offers a more affordable alternative without compromising quality.”.

“在临床实践中，拥有更广泛的治疗选择可以增强医生根据患者个人需求调整治疗方案的能力。阿柏西普一直是管理视网膜疾病的关键药物，而Aflivu的推出提供了一个更经济实惠且不降低质量的选择。”