With the development of innovative cancer treatments over recent decades, the cost of cancer care has risen exponentially, limiting patient access to patented originator biotherapeutics in many countries. The introduction of biosimilars to the market has created new opportunities as well the need for changes in practice within healthcare institutions. A ‘biosimilar’ is a biotherapeutic product which is highly similar in terms of quality, safety and efficacy to an already licensed originator product. Although biosimilars lack clinically meaningful differences in therapeutic activity as compared to the originator product, these complex biological molecules are not considered identical chemical copies, unlike generics, and minor differences in molecular structure and inactive compounds may exist. A thorough understanding of these differences and their clinical implications is necessary for optimising medicines-use practices involving biosimilars. This position statement, developed by the International Society of Oncology Pharmacy Practitioners Biosimilars Taskforce, aims to provide the global oncology pharmacy community with guidance to support decisions around biosimilar use. The 11 statements cover the regulation and evaluation of biosimilars, practical issues around local implementation, the education of healthcare staff and patients, and the requirement for ongoing pharmacovigilance and outcome monitoring.

译文

:随着近几十年来创新型癌症治疗方法的发展,癌症治疗的费用成倍增加,在许多国家限制了患者使用获得专利的生物治疗药物的机会。将生物仿制药推向市场不仅创造了新的机遇,还为医疗机构内部的实践变革带来了需求。 “生物仿制药”是一种生物治疗产品,其质量,安全性和功效与已获许可的原始产品高度相似。尽管与仿制药相比,生物仿制药在治疗活性上缺乏临床上有意义的差异,但与仿制药不同,这些复杂的生物分子不被视为相同的化学拷贝,并且分子结构和非活性化合物可能存在细微差异。对这些差异及其临床意义的透彻了解对于优化涉及生物仿制药的药物使用实践是必不可少的。该立场声明是由国际肿瘤药学从业者协会生物仿制药特别工作组制定的,旨在为全球肿瘤药学界提供指导,以支持围绕生物仿制药使用的决策。这11项声明涵盖生物仿制药的监管和评估,本地实施的实际问题,医护人员和患者的教育以及持续进行药物警戒和结果监测的要求。

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