The case study described in this paper was developed for the purpose of training for a better understanding of principles relating especially to a comprehensive evaluation of multiple quality attributes as outlined in the WHO guidelines on evaluation of similar biotherapeutic products. It is also to emphasize the importance of an understanding of the critical quality attributes and a risk assessment of the impact on clinical performance. It was prepared to mimic a real situation in which regulators need to evaluate the differences in quality attributes known to have potential impact on clinical activity. Erythropoietin has been identified as one of the important glycosylated therapeutic proteins and a good example to illustrate how structural characteristics would affect product efficacy and safety. The case study illustrates biosimilarity assessment of a candidate of erythropoietin biosimilar and the important quality attributes that need to be considered in order to understand the importance of structure-function relationships as they contribute to the stepwise evaluation of biosimilarity. This paper reflects the outcomes of the case study exercise and discussion from two WHO implementation workshops held in Ghana (September 2015) and Denmark (July 2017).

本文描述的案例研究是为了培训目的而开发的，目的是为了更好地理解有关原则，尤其是与WHO质量相似生物治疗产品评估指南中概述的多种质量属性的综合评估有关的原则。还应强调理解关键质量属性和对临床表现影响进行风险评估的重要性。它准备模仿现实情况，在这种情况下，监管机构需要评估已知会对临床活动产生潜在影响的质量属性的差异。促红细胞生成素已被认为是重要的糖基化治疗蛋白之一，也是说明结构特征如何影响产品功效和安全性的一个很好的例子。案例研究说明了促红细胞生成素生物仿制药候选物的生物相似性评估以及重要的质量属性，为了理解结构功能关系的重要性，因为它们有助于逐步评估生物相似性，因此需要考虑这些重要的质量属性。