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Rituximab biosimilars

机译：利妥昔单抗生物仿制药

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Introduction: Rituximab is a monoclonal antibody targeting CD20, used to treat B cell malignancies and B cell-mediated autoimmune diseases. Rituximab has the largest market of any monoclonal antibody therapeutic. Its patent will expire within the next few years and several manufacturers have already produced or are developing rituximab biosimilars that aim to match the innovator rituximab as closely as possible. Areas covered: In this review, we discuss key factors that determine the efficacy of rituximab therapy, potential technical challenges in the manufacture and evaluation of biosimilars, regulatory considerations regarding the review and approval of biosimilars, and the current status of biosimilar rituximab development by various manufacturers. Due to the nature of the topic, literature searches included conference abstracts, regulatory and industry websites as well as peer reviewed literature. Expert opinion: Cost is a key limitation of current biologics usage and there is a political impetus to the licensing of biosimilars. Concerns regarding potential dissimilarities of biosimilars are legitimate, but surmountable with techniques for in vitro, in vivo and clinical testing and more clearly defined regulatory requirements. These should provide reassurance to prescribers. However, the cost of manufacturing and licensing a biosimilar remains high and the reduction in cost may be more limited than for a non-biologic small molecule drug and its generic version. This cost reduction will be critical to the impact and use of rituximab biosimilars.
机译：简介：利妥昔单抗是靶向CD20的单克隆抗体，用于治疗B细胞恶性肿瘤和B细胞介导的自身免疫性疾病。利妥昔单抗在所有单克隆抗体治疗药物中拥有最大的市场。它的专利将在未来几年内到期，几家制造商已经生产或正在开发利妥昔单抗生物仿制药，旨在尽可能与创新者利妥昔单抗匹配。涵盖的领域：在这篇综述中，我们讨论了决定利妥昔单抗治疗效果的关键因素，生物仿制药的生产和评估中的潜在技术挑战，有关生物仿制药的审批的监管注意事项以及各种生物仿制药利妥昔单抗开发的现状制造商。由于主题的性质，文献搜索包括会议摘要，监管和行业网站以及同行评审的文献。专家意见：成本是当前生物制剂使用的关键限制，并且对生物仿制药的许可具有政治上的推动力。有关生物仿制药潜在差异的担忧是合理的，但可以通过体外，体内和临床测试技术以及更明确定义的监管要求来克服。这些应该为处方者提供保证。但是，生物仿制药的生产和许可成本仍然很高，与非生物小分子药物及其仿制药相比，其成本下降的局限性可能更大。降低成本对于利妥昔单抗生物仿制药的影响和使用至关重要。

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