The recent expiration of several protein therapeutics opened the door for biosimilar development. Biosimilars are biologic medical products that are similar but not identical copies of already-authorized protein therapeutics. Critical quality attributes (CQA), such as post-translational modifications of recombinant biotherapeutics, are important for the clinical efficacy and safety of both the innovative biologics and their biosimilar counterparts. Here, we summarize biosimilarity CQAs, considering the regulatory guidelines and the statistical aspects (e.g., biosimilarity index) and then discuss glycosylation as one of the important attributes of biosimilarity. Finally, we introduced the ‘Glycosimilarity Index’, which is based on the averaged biosimilarity criterion.

几种蛋白质治疗剂的最近到期为生物仿制药的开发打开了大门。生物仿制药是生物医学产品，与已获准的蛋白质治疗药物相似但不完全相同。关键质量属性（CQA），例如重组生物治疗药物的翻译后修饰，对于创新型生物制剂及其类似生物制剂的临床疗效和安全性至关重要。在这里，我们总结了生物相似性CQA，同时考虑了监管指南和统计方面（例如，生物相似性指数），然后讨论了糖基化是生物相似性的重要属性之一。最后，我们介绍了基于平均生物相似性标准的“糖相似性指数”。