Biosimilars in pediatric rheumatology: innovations, challenges, and opportunities.

IF 3.6 3区医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Expert Opinion on Biological Therapy Pub Date : 2025-01-13 DOI:10.1080/14712598.2025.2453516

Ali Öksel, Hafize Emine Sönmez, Nihal Şahin

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Abstract

Introduction: Biosimilars are biologic medications designed to closely replicate the properties of previously approved biologic disease-modifying anti-rheumatic drugs (bDMARDs). They offer a cost-effective alternative once the original product's patent has expired.

Areas covered: In pediatric rheumatology, the use of biosimilars began in 2013 with the launch of the infliximab biosimilar. Since then, more biosimilars, including etanercept, rituximab, and adalimumab, have been introduced, providing additional treatment options for children with rheumatic diseases. This article explores the role of biosimilars in pediatric rheumatology, particularly in juvenile idiopathic arthritis, focusing on their development, safety, and efficacy, as well as the challenges associated with their clinical adoption. It also addresses the importance of education in improving understanding of biosimilars.

Expert opinion: The article provides insights into their safety, effectiveness, and economic impact by reviewing current literature to help healthcare professionals make informed decisions for treating pediatric rheumatic diseases. Education for both patients and healthcare providers, effective communication, and expectation management play a critical role in ensuring appropriate treatment continuity.

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简介：生物仿制药是一种生物制药，旨在近似复制先前获批的生物改变病情抗风湿药（bDMARDs）的特性。一旦原产品的专利到期，生物仿制药将成为一种具有成本效益的替代品：在儿科风湿病学领域，生物仿制药的使用始于2013年英夫利西单抗生物仿制药的上市。此后，包括依那西普、利妥昔单抗和阿达木单抗在内的更多生物仿制药相继问世，为风湿病患儿提供了更多的治疗选择。本文探讨了生物仿制药在儿科风湿病学中的作用，尤其是在幼年特发性关节炎中的作用，重点关注其发展、安全性和疗效，以及与临床应用相关的挑战。文章还论述了教育在提高人们对生物仿制药的认识方面的重要性：文章通过回顾当前的文献，深入分析了生物仿制药的安全性、有效性和经济影响，以帮助医疗保健专业人员在治疗小儿风湿病时做出明智的决定。对患者和医护人员的教育、有效沟通和期望管理在确保适当治疗的连续性方面发挥着至关重要的作用。

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

Expert Opinion on Biological Therapy 医学-生物工程与应用微生物

CiteScore

8.60

自引率

0.00%

发文量

审稿时长

3-8 weeks

期刊介绍： Expert Opinion on Biological Therapy (1471-2598; 1744-7682) is a MEDLINE-indexed, international journal publishing peer-reviewed research across all aspects of biological therapy. Each article is structured to incorporate the author’s own expert opinion on the impact of the topic on research and clinical practice and the scope for future development. The audience consists of scientists and managers in the healthcare and biopharmaceutical industries and others closely involved in the development and application of biological therapies for the treatment of human disease. The journal welcomes: Reviews covering therapeutic antibodies and vaccines, peptides and proteins, gene therapies and gene transfer technologies, cell-based therapies and regenerative medicine Drug evaluations reviewing the clinical data on a particular biological agent Original research papers reporting the results of clinical investigations on biological agents and biotherapeutic-based studies with a strong link to clinical practice Comprehensive coverage in each review is complemented by the unique Expert Collection format and includes the following sections: Expert Opinion – a personal view of the data presented in the article, a discussion on the developments that are likely to be important in the future, and the avenues of research likely to become exciting as further studies yield more detailed results; Article Highlights – an executive summary of the author’s most critical points.