Efficacy, safety, and cost-effectiveness of biosimilars of bevacizumab in näive patients with diabetic macular edema.

IF 1.4 4区医学 Q4 PHARMACOLOGY & PHARMACY

Indian Journal of Pharmacology Pub Date : 2024-09-10 DOI:10.4103/ijp.ijp_58_24

Shalini Virani,Akshay Bhatiwal,Parveen Rewri

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引用次数: 0

Abstract

OBJECTIVES Anti-vascular endothelial growth factor (VEGF) therapy restores retinal architecture and enhances vision in diabetic macular edema (DME). Bevacizumab is an off-label anti-VEGF drug that effectively treats DME. The safety and efficacy of bevacizumab biosimilars, which are more affordable than the original medication, still need to be established. This study aimed to assess the cost-effectiveness, efficacy, and safety of biosimilars for treating patients with naïve DME across various price ranges that are accessible in the Indian market. MATERIALS AND METHODS Two biosimilars, BevaciRelTM (Reliance Life Sciences Pvt. Ltd.) and ZyBev (Cadila Healthcare Limited), were compared to their original, Avastin (Roche Products [India] Pvt. Ltd.), in a randomized, control study. Three end-notes were used to assess safety and efficacy: persistence, improvement, and adverse events. Cost-effective analysis was carried out using a decision-tree analysis model. RESULTS This study included 69 (59%) men and 54 (41%) women with naïve DME. The cohort had an average log MAR visual acuity of 0.87 ± 0.22, and the central retinal thickness at baseline on OCT was 398.5 ± 37.61 μm. The visual acuity showed a similar improvement, and there was a decrease in central retinal thickness as observed on OCT across the groups. The incremental cost-effectiveness ratio was 10.8. CONCLUSIONS The biosimilars of bevacizumab are safe and efficacious in treating DME in a cost-effective manner.

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贝伐珠单抗生物仿制药在糖尿病黄斑水肿患者中的疗效、安全性和成本效益。

目的：抗血管内皮生长因子（VEGF）疗法可恢复糖尿病性黄斑水肿（DME）患者的视网膜结构并提高视力。贝伐珠单抗是一种非标签抗血管内皮生长因子药物，可有效治疗 DME。贝伐珠单抗生物仿制药比原研药价格更低，但其安全性和有效性仍有待确定。本研究旨在评估生物仿制药治疗印度市场上不同价格范围的新发 DME 患者的成本效益、疗效和安全性。材料和方法在一项随机对照研究中，将两种生物仿制药 BevaciRelTM（Reliance Life Sciences Pvt.在评估安全性和有效性时使用了三个最终指标：持续性、改善性和不良事件。该研究纳入了 69 名（59%）男性和 54 名（41%）女性新发 DME 患者。组群的平均对数 MAR 视力为 0.87 ± 0.22，基线 OCT 视网膜中心厚度为 398.5 ± 37.61 μm。各组的视力改善情况相似，OCT 观察到的视网膜中心厚度也有所下降。增量成本效益比为 10.8。结论贝伐珠单抗的生物仿制药在治疗 DME 方面安全有效，且成本效益高。

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来源期刊

Indian Journal of Pharmacology 医学-药学

CiteScore

4.00

自引率

4.20%

发文量

审稿时长

4-8 weeks

期刊介绍： Indian Journal of Pharmacology accepts, in English, review articles, articles for educational forum, original research articles (full length and short communications), letter to editor, case reports and interesting fillers. Articles concerning all aspects of pharmacology will be considered. Articles of general interest (e.g. methods, therapeutics, medical education, interesting websites, new drug information and commentary on a recent topic) are also welcome.