Biocon Biologics has received a notice of compliance (NOC) from Health Canada for Yesafili (aflibercept 2 mg), a biosimilar to Eylea, available in both vial and prefilled syringe presentations at 2 mg/0.05 mL.

Biocon Biologics 已收到加拿大卫生部关于 Yesafili（阿柏西普 2 mg）的合规通知 (NOC)，该药物是 Eylea 的生物类似药，有 2 mg/0.05 mL 的小瓶和预填充注射器两种形式。

Indications for Yesafili in Retinal Diseases

叶沙菲利在视网膜疾病中的应用指征

Yesafili is a VEGF inhibitor indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema (DME), visual impairment due to macular edema secondary to central retinal vein occlusion and branch retinal vein occlusion, and myopic choroidal neovascularization..

Yesafili是一种VEGF抑制剂，适用于治疗新生血管性（湿性）年龄相关性黄斑变性（AMD）、糖尿病性黄斑水肿（DME）、因中央视网膜静脉阻塞和分支视网膜静脉阻塞引起的继发性黄斑水肿导致的视力损害，以及近视性脉络膜新生血管化。

Approval Based on Robust Analytical and Clinical Data

基于强大的分析和临床数据的批准

Biocon Biologics noted that Health Canada’s approval of Yesafili was supported by a comprehensive set of analytical, nonclinical, and clinical data, demonstrating that Yesafili is highly similar to Eylea with no clinically meaningful differences in quality, safety, or efficacy.

Biocon Biologics 表示，加拿大卫生部对 Yesafili 的批准得到了一套全面的分析、非临床和临床数据的支持，证明 Yesafili 与 Eylea 高度相似，在质量、安全性和有效性方面没有临床意义上的差异。

First Biosimilar to Eylea Approved in Canada

加拿大批准首个Eylea生物类似药

“The approval of Yesafili by Health Canada—the first biosimilar to Eylea in Canada—is a proud moment for Biocon Biologics. We are excited that in July, Canada will be the first country where we will launch Yesafili, making it our 10th biosimilar to be commercialized worldwide,” said Shreehas Tambe, CEO and Managing Director of Biocon Biologics, in a company press release.

“加拿大卫生部批准Yesafili——这是加拿大首个Eylea的生物类似药——对Biocon Biologics来说是一个值得骄傲的时刻。我们非常兴奋，今年7月，加拿大将成为我们推出Yesafili的首个国家，这也将成为我们在全球商业化的第10个生物类似药，”Biocon Biologics首席执行官兼董事总经理Shreehas Tambe在公司新闻稿中表示。

Launch Set for July 2025

定于2025年7月发射

Biocon Biologics plans to launch Yesafili in Canada on July 4, 2025. This milestone makes Yesafili the first biosimilar to Eylea approved by Health Canada, expanding treatment options for patients with retinal vascular diseases.

Biocon Biologics 计划于 2025 年 7 月 4 日在加拿大推出 Yesafili。这一里程碑使 Yesafili 成为首个获加拿大卫生部批准的 Eylea 生物类似药，为视网膜血管疾病患者扩展了治疗选择。