生物相似药的安全性规格必须与原始生物制品相似是非常关键的。医疗服务提供者为了给接受潜在严重不良事件（AEs）的化疗治疗的生命威胁癌症患者开处方，需要更好地了解生物相似药和它们相对的安全性和免疫原性规格。本研究的目的是汇总和分析肿瘤学中生物相似药的安全性与免疫原性的结果，并将它们与原始生物制品的安全信息进行比较。MEDLINE和Cochrane Library数据库截止2022年2月28日进行了搜索。研究考虑了4种抗癌生物相似分子：贝伐珠单抗、曲妥珠单抗、利妥昔单抗和长效粒细胞集落刺激因子或聚乙二醇化长效粒细胞集落刺激因子。通过系统评价，我们选择比较四种分子的生物相似药和原始生物制品之间的安全性结果的随机对照试验（RCTs）。各种治疗相关的不良事件（TEAEs）被汇总，例如任何TEAE、严重AE和高于3级的TEAE。风险比（RR）根据TEAE每个类别估计其值之间的一致性。此外，还进行了网络荟萃分析（NMA），以比较生物相似品牌的安全性，其中TEAE超过25％且变异性更高，此外还比较了严重的AE病例。我们确定了49个RCT。元分析的结果显示，在TEAE水平上，所有四种生物相似药分子的安全性和免疫性规格与原始生物制品相当，但较少的腹泻发生率是（聚）粒细胞集落刺激因子相似药的特例（与原始生物制品相比，RR为0.66，95％置信区间为0.50-0.89）。 NMA结果显示，在所有四种生物相似药分子中，除曲妥珠单抗生物相似物的严重不良事件（RR为0.296，95％可信区间为0.109-0.840）之外，所有生物相似品牌的安全性和免疫性规格都相似。所有四种生物相似药物的元分析和NMA显示，在TEAE水平上，肿瘤学中的生物相似品的安全性和免疫原性规格通常与原始生物制品相似。但是，需要收集更多证据，因为某些生物相似药的特定TEAE超出了等效范围。本研究的结果为医疗服务提供者提供了比较安全的信息和更好地了解肿瘤学生物相似药。 © 2023. 作者（s）在独家许可下转让给Springer Nature Switzerland AG。

It is crucial that the safety profiles of biosimilars are similar to those of the original biologics. A better understanding of biosimilars and their relative safety and immunogenicity profiles are required for healthcare providers to prescribe them to patients with life-threatening cancer diseases who receive chemotherapies with potentially serious adverse events (AEs).The purpose of this study was to collate and analyze currently available safety and immunogenicity outcomes of biosimilars used in oncology and compare their safety information with those of the original biologics.The MEDLINE and Cochrane Library databases were searched as at 28 February 2022. Four anti-cancer biosimilar molecules were considered: bevacizumab, trastuzumab, rituximab, and (peg)filgrastim. Through a systematic review, we selected the randomized controlled trials (RCTs) comparing safety outcomes between the biosimilars and original biologics of the four molecules. As safety outcomes, various treatment-emergent adverse events (TEAEs) were collated, such as any TEAE, serious AE, and TEAE higher than grade 3. A risk ratio (RR) per category of TEAE was estimated through a meta-analysis. A network meta-analysis (NMA) was also conducted to compare the safety among the biosimilar brands for TEAEs over 25% with higher variability in addition to the serious AE cases.Forty-nine RCTs were identified. The results from the meta-analysis showed that the safety and immunogenicity profiles of all four biosimilar molecules are comparable with that of the original biologics at the TEAE level without statistically significant differences, except for diarrhea for (peg)filgrastim. The incidence of diarrhea with (peg)filgrastim was less than that with the original biologic (RR 0.66, 95% confidence interval 0.50-0.89). The NMA results showed similar safety profiles among the biosimilar brands for all four biosimilar molecules, except for the serious adverse event of a trastuzumab biosimilar (RR 0.296, 95% credible interval 0.109-0.840).The meta-analysis and NMA for all four biosimilars showed that the safety and immunogenicity profiles of biosimilar products in oncology are generally comparable with that of the original biologics at the TEAE level. However, additional evidence needs to be collected since several TEAEs of specific biosimilars were out of the equivalent range. The results of this study provide comparative safety information and a better understanding of oncology biosimilars for healthcare providers to prescribe them to patients.© 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.