SDZ-AFL: An Aflibercept Biosimilar.

IF 2.7 3区医学 Q2 PHARMACOLOGY & PHARMACY

Clinical Drug Investigation Pub Date : 2025-09-01 Epub Date: 2025-07-24 DOI:10.1007/s40261-025-01458-3

Yahiya Y Syed

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引用次数: 0

Abstract

SDZ-AFL (SOK583A1; Afqlir^®) is a biosimilar of the reference intravitreal aflibercept, a vascular endothelial growth factor inhibitor. SDZ-AFL has been approved in the EU for the treatment of the same indications in adults as reference aflibercept: neovascular age-related macular degeneration (nAMD), visual impairment due to macular oedema secondary to retinal vein occlusion, visual impairment due to diabetic macular oedema and visual impairment due to myopic choroidal neovascularisation. SDZ-AFL has similar physicochemical and pharmacodynamic properties to those of reference aflibercept, and pharmacokinetic similarity has been demonstrated in patients with nAMD. SDZ-AFL demonstrated clinical efficacy equivalent to that of reference aflibercept in patients with nAMD and was generally well tolerated in this population. The tolerability, safety and immunogenicity profiles of SDZ-AFL were similar to those of reference aflibercept. The role of reference aflibercept in the management of neovascular retinal diseases is well established, and SDZ-AFL provides an effective biosimilar alternative for patients requiring ophthalmic aflibercept therapy.

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生物模拟的影响。

SDZ-AFL (SOK583A1;Afqlir®)是参考玻璃体内afliberept的生物仿制药，afliberept是一种血管内皮生长因子抑制剂。SDZ-AFL已在欧盟获得批准，用于治疗与阿布利塞普相同的成人适应症：新生血管性年龄相关性黄斑变性（nAMD）、继发于视网膜静脉阻塞的黄斑水肿导致的视力损害、糖尿病性黄斑水肿导致的视力损害和近视脉络膜新生血管导致的视力损害。SDZ-AFL与参比药物阿伯西普具有相似的物理化学和药效学性质，并且在nAMD患者中已证实药代动力学相似。在nAMD患者中，SDZ-AFL的临床疗效与参考药物阿布西普相当，并且在该人群中耐受性良好。SDZ-AFL的耐受性、安全性和免疫原性与参比afliberept相似。参考阿非利赛普在新血管性视网膜疾病治疗中的作用已得到证实，SDZ-AFL为需要阿非利赛普眼科治疗的患者提供了一种有效的生物仿制药替代方案。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical Drug Investigation 医学-药学

CiteScore

5.90

自引率

3.10%

发文量

108

审稿时长

6-12 weeks

期刊介绍： Clinical Drug Investigation provides rapid publication of original research covering all phases of clinical drug development and therapeutic use of drugs. The Journal includes: -Clinical trials, outcomes research, clinical pharmacoeconomic studies and pharmacoepidemiology studies with a strong link to optimum prescribing practice for a drug or group of drugs. -Clinical pharmacodynamic and clinical pharmacokinetic studies with a strong link to clinical practice. -Pharmacodynamic and pharmacokinetic studies in healthy volunteers in which significant implications for clinical prescribing are discussed. -Studies focusing on the application of drug delivery technology in healthcare. -Short communications and case study reports that meet the above criteria will also be considered. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Clinical Drug Investigation may be accompanied by plain language summaries to assist readers who have some knowledge, but non in-depth expertise in, the area to understand important medical advances.