AVT04: An Ustekinumab Biosimilar.

IF 2.9 3区医学 Q2 PHARMACOLOGY & PHARMACY Clinical Drug Investigation Pub Date : 2024-07-01 Epub Date: 2024-07-04 DOI:10.1007/s40261-024-01375-x

Hannah A Blair

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Abstract

AVT04 (Uzpruvo^®) is a biosimilar of the reference anti-interleukin (IL)-12 and IL-23 monoclonal antibody ustekinumab. It is approved in the EU for plaque psoriasis, paediatric plaque psoriasis, psoriatic arthritis and Crohn's disease as per the reference product. AVT04 has similar physicochemical characteristics to those of reference ustekinumab, and the pharmacokinetic similarity of the agents has been shown in healthy volunteers and patients with moderate to severe chronic plaque psoriasis. AVT04 demonstrated clinical efficacy similar to that of reference ustekinumab in patients with moderate to severe chronic plaque psoriasis, and was generally well tolerated in this population. The tolerability, safety and immunogenicity profiles of AVT04 were similar to those of reference ustekinumab, and switching from reference ustekinumab to AVT04 had no impact on efficacy, safety or immunogenicity. The role of reference ustekinumab in the management of inflammatory diseases is well established and AVT04 provides an effective biosimilar alternative for patients requiring ustekinumab therapy.

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AVT04：乌司替吉单抗生物仿制药。

AVT04 (Uzpruvo®) 是抗白细胞介素 (IL)-12 和 IL-23 单克隆抗体乌斯特库单抗的生物类似药。它在欧盟被批准用于治疗斑块状银屑病、儿童斑块状银屑病、银屑病关节炎和克罗恩病，与参照产品相同。AVT04 的理化特性与参比乌司替尼相似，在健康志愿者和中重度慢性斑块状银屑病患者中的药代动力学也显示出相似性。在中重度慢性斑块状银屑病患者中，AVT04 的临床疗效与参考药物乌司替库单抗相似，而且这些患者的耐受性普遍良好。AVT04的耐受性、安全性和免疫原性与参比乌司替库单抗相似，从参比乌司替库单抗换成AVT04对疗效、安全性和免疫原性没有影响。参考药物乌司替库单抗在炎症性疾病治疗中的作用已得到充分肯定，AVT04为需要乌司替库单抗治疗的患者提供了一种有效的生物仿制药替代品。

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.