The World Health Organization (WHO) issued guidelines for the regulatory evaluation of biosimilars in 2009 and has provided considerable effort toward helping member states implement the evaluation principles in the guidelines into their regulatory practices. Despite this effort, a recent WHO survey (conducted in 2019-2020) has revealed four main remaining challenges: unavailable/insufficient reference products in the country; lack of resources; problems with the quality of some biosimilars (and even more with noninnovator products); and difficulties with the practice of interchangeability and naming of biosimilars. The following have been identified as opportunities/solutions for regulatory authorities to deal with the existing challenges: (1) exchange of information on products with other regulatory authorities and accepting foreign licensed and sourced reference products, hence avoiding conducting unnecessary (duplicate) bridging studies; (2) use of a "reliance" concept and/or joint review for the assessment and approval of biosimilars; (3) review and reassessment of the products already approved before the establishment of a regulatory framework for biosimilar approval; and (4) setting appropriate regulatory oversight for good pharmacovigilance, which is essential for the identification of problems with products and establishing the safety and efficacy of interchangeability of biosimilars.

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生物仿制药的监管挑战：来自 20 个国家的最新情况

世界卫生组织 (WHO) 于 2009 年发布了生物仿制药监管评估指南，并为帮助成员国将指南中的评估原则落实到其监管实践中做出了巨大努力。尽管如此，世卫组织最近的一项调查（于 2019-2020 年进行）揭示了四个主要的挑战：该国参考产品不可用/不足；缺乏资源; 一些生物仿制药的质量问题（非创新产品更是如此）；以及在生物仿制药的互换性和命名实践中遇到的困难。以下已被确定为监管机构应对现有挑战的机会/解决方案：(1) 与其他监管机构交换产品信息，接受国外许可和采购的参考产品，从而避免进行不必要的（重复）桥接研究；(2) 使用“依赖”概念和/或联合审查来评估和批准生物仿制药；（三）在生物类似药审批监管框架建立前，对已获批产品进行审查和再评估；(4) 为良好的药物警戒设置适当的监管监督，这对于识别产品问题和建立生物仿制药互换性的安全性和有效性至关重要。生物仿制药评估和批准的概念和/或联合审查；（三）在生物类似药审批监管框架建立前，对已获批产品进行审查和再评估；(4) 为良好的药物警戒设置适当的监管监督，这对于识别产品问题和建立生物仿制药互换性的安全性和有效性至关重要。生物仿制药评估和批准的概念和/或联合审查；（三）在生物类似药审批监管框架建立前，对已获批产品进行审查和再评估；(4) 为良好的药物警戒设置适当的监管监督，这对于识别产品问题和建立生物仿制药互换性的安全性和有效性至关重要。