与参考利妥昔单抗 (Mabthera) 相比，利妥昔单抗生物仿制药的临床安全性和有效性已在随机试验中得到充分证实。然而，对于从参比产品更换为生物仿制药的安全性仍然存在担忧，特别是在不同的生物仿制药之间。这项前瞻性多中心观察研究是在意大利 8 个地区的 13 个肿瘤血液学单位进行的。该研究纳入了 800 名在 2018 年 3 月至 2022 年 6 月期间接受利妥昔单抗治疗的非霍奇金淋巴瘤 (NHL) 或慢性淋巴细胞白血病 (CLL) 患者。为了尽量减少生存偏差，仅纳入新诊断的患者（即既往未接受利妥昔单抗治疗的患者）药物不良反应（ADR）分析。因此，本研究重点关注来自 13 个中心的 505 起事件病例（占初始队列的 79.8%）。总共进行了 3681 次利妥昔单抗输注，16.8% 的患者经历了至少 1 次 ADR。这些在第一次输注（44 名患者，52%）和第二次输注（17 名患者，20%）期间最常见。最常见的反应是一般疾病和给药部位状况（n. 50，8% 严重）。这些发现支持利妥昔单抗生物仿制药的临床安全性，并表明生物仿制药之间的转换不会增加不良事件的风险。这一证据可能会减轻人们对生物仿制药使用的担忧，从而有可能获得更广泛的接受并降低医疗成本。

The clinical safety and efficacy of rituximab biosimilars compared to the reference rituximab (Mabthera) have been well established in randomized trials. However, concerns persist regarding the safety of changing from the reference product to biosimilars, and particularly between different biosimilars. This prospective multicenter observational study was conducted in 13 oncohematology units of eight Italian regions. The study included 800 patients with non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL) who received rituximab between March 2018 and June 2022. To minimize survivorship bias, only newly diagnosed patients (i.e., those without prior rituximab treatment) were included in the analysis of adverse drug reactions (ADRs). Thus, this study focused on 505 incident cases (79.8% of the initial cohort) from 13 centers. A total of 3681 rituximab infusions were administered, and 16.8% of the patients experienced at least one ADR. These were observed most frequently during the first infusion (44 patients, 52%) and the second infusion (17 patients, 20%). The most frequent reactions were general disorders and administration site conditions (n. 50, 8% serious). These findings support the clinical safety of rituximab biosimilars and suggest that switching between biosimilars does not increase the risk of adverse events. This evidence may alleviate concerns about biosimilar use, potentially leading to broader acceptance and reduced healthcare costs.