Rioufol Catherine, Salles Gilles
Hospices Civils de Lyon, Unité de Pharmacie Clinique Oncologique, Université de Lyon - EMR 3738, Pierre-Bénite, France.
Expert Rev Anticancer Ther. 2015 May;15(5):569-78. doi: 10.1586/14737140.2015.1028919. Epub 2015 Mar 30.
Rituximab, an anti-CD20 monoclonal antibody, revolutionized the treatment of lymphoma. Although newer generation anti-CD20 monoclonal antibodies are being examined, patent expiries and patient demand have fueled the development of rituximab biosimilars. The development of such agents is both an important and difficult undertaking. By definition, although they aim to have safety and efficacy comparable with their reference agents, biosimilars are not exact replicas of those agents, and small changes in nonclinical and preclinical properties may ultimately affect in vivo activity. Consideration must be given to the complex mechanisms of action, sensitive patient populations that may be treated, and appropriate clinical trial endpoints. Furthermore, extrapolation of indications is multifaceted, deserving close examination. This review represents a critical look at biosimilars in lymphoma and their safety, efficacy and long-term effects on patient outcomes.
利妥昔单抗，一种抗CD20单克隆抗体，彻底改变了淋巴瘤的治疗方式。尽管新一代抗CD20单克隆抗体正在接受研究，但专利到期和患者需求推动了利妥昔单抗生物类似药的开发。此类药物的开发是一项既重要又艰巨的任务。根据定义，生物类似药虽然旨在具有与参照药物相当的安全性和有效性，但并非这些药物的精确复制品，非临床和临床前特性的微小变化最终可能会影响体内活性。必须考虑其复杂的作用机制、可能接受治疗的敏感患者群体以及合适的临床试验终点。此外，适应症的外推是多方面的，值得仔细研究。本综述对淋巴瘤生物类似药及其安全性、有效性以及对患者预后的长期影响进行了批判性审视。
