With the projected expansion of the biosimilars market, there will be an increased propensity for the substitution of reference biological products with cheaper biosimilars for economic reasons (ie, non-medical switching). This will lower the cost per patient and should provide the benefit of wider access to biological therapies. However, it is essential that patients and clinicians fully understand the rationale for non-medical switching and its potential implications in terms of efficacy, safety, and immunogenicity. To date, clinical experience supports the use of biosimilars and a growing body of evidence from clinical trials and real world observational studies specifically supports clinical decision making around non-medical switching. Equally, as non-medical switching becomes more common, it is essential that pharmacovigilance systems adapt to handle the increasing volumes of data needed to effectively monitor the use of biosimilars and detect new signals. This will require a reduced reliance on registries, as well as streamlining and integration of existing systems to allow a frequent cycle of online reporting of adverse events by healthcare professionals, analysis by national authorities, and feedback to treating clinicians. This article considers the current use and future uptake of biosimilars from a clinical perspective.

中文翻译：

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生物仿制药：临床实践的考虑

随着生物仿制药市场的预期扩张，出于经济原因（即非医疗转换），用更便宜的生物仿制药替代参考生物制品的倾向将增加。这将降低每位患者的成本，并应提供更广泛地获得生物疗法的好处。然而，患者和临床医生必须充分了解非医疗转换的基本原理及其在疗效、安全性和免疫原性方面的潜在影响。迄今为止，临床经验支持生物仿制药的使用，越来越多来自临床试验和现实世界观察研究的证据特别支持围绕非医疗转换的临床决策。同样，随着非医疗转换变得越来越普遍，药物警戒系统必须适应处理有效监测生物仿制药使用和检测新信号所需的不断增加的数据量。这将需要减少对登记的依赖，并简化和整合现有系统，以允许医疗保健专业人员在线报告不良事件、国家当局进行分析以及向治疗临床医生提供反馈的频繁循环。本文从临床角度考虑了生物仿制药的当前使用和未来吸收。以及现有系统的精简和整合，以允许医疗保健专业人员在线报告不良事件、国家当局进行分析以及向治疗临床医生提供反馈的频繁循环。本文从临床角度考虑了生物仿制药的当前使用和未来吸收。以及现有系统的精简和整合，以允许医疗保健专业人员在线报告不良事件、国家当局进行分析以及向治疗临床医生提供反馈的频繁循环。本文从临床角度考虑了生物仿制药的当前使用和未来吸收。