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BioDrugs. 2017 Jun;31(3):275-278. doi: 10.1007/s40259-017-0226-5.
CT-P10 (Truxima™) is the first biosimilar of the reference monoclonal anti-CD20 antibody rituximab. It is approved for use in all indications for which reference rituximab is approved, including follicular lymphoma (FL), diffuse large B-cell non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis (RA), granulomatosis with polyangiitis and microscopic polyangiitis. CT-P10 has similar physicochemical and pharmacodynamic properties to those of reference rituximab, and the pharmacokinetic biosimilarity of the agents has been shown in patients with RA or FL. CT-P10 demonstrated clinical efficacy equivalent to that of reference rituximab in patients with RA, and was generally well tolerated in this population as well as in patients with FL. The tolerability, immunogenicity and safety profiles of CT-P10 were similar to those of reference rituximab, and switching from reference rituximab to CT-P10 had no impact on safety or efficacy. The role of reference rituximab in the management of autoimmune conditions and cancers is well established and CT-P10 provides an effective biosimilar alternative for patients requiring rituximab therapy.
CT-P10（Truxima™）是首个参照抗 CD20 单克隆抗体利妥昔单抗的生物类似药。它被批准用于参照利妥昔单抗已获批的所有适应证，包括滤泡性淋巴瘤（FL）、弥漫性大 B 细胞非霍奇金淋巴瘤、慢性淋巴细胞白血病、类风湿关节炎（RA）、肉芽肿性多血管炎和显微镜下多血管炎。CT-P10 与参照利妥昔单抗具有相似的理化特性和药效动力学特性，在 RA 或 FL 患者中已证实其具有相似的药代动力学特征。CT-P10 在 RA 患者中显示出与参照利妥昔单抗等效的临床疗效，并且在该人群以及 FL 患者中通常具有良好的耐受性。CT-P10 的耐受性、免疫原性和安全性特征与参照利妥昔单抗相似，从参照利妥昔单抗转换为 CT-P10 对安全性或疗效没有影响。参照利妥昔单抗在自身免疫性疾病和癌症治疗中的作用已得到充分证实，CT-P10 为需要利妥昔单抗治疗的患者提供了一种有效的生物类似药替代方案。
