生物治疗药物和生物类似药研究进展

发布时间：2018-03-20 05:08

本文选题：生物治疗药物　切入点：原研药　出处：《中国新药杂志》2017年03期 　论文类型：期刊论文

【摘要】：生物治疗药物已广泛应用于各个疾病治疗领域,随着早期生物制品专利和数据保护到期,国际上掀起了生物类似药(biosimilars)开发的浪潮。生物类似药是指与生物原研药含有相似的活性物质,在质量、安全性和有效性方面与原研药具有相似性,临床意义上无差异的药物。由于生物类似药可以更好地满足公众对生物治疗产品的需求,有助于提高生物药的可及性和降低价格。另一方面,因为生物治疗药物的独特性和复杂性,生物类似药不可能与原研药完全相同。"化学仿制药"的评价原则和法规不适用于生物类似药。许多国家都十分重视生物类似药的研发和管理工作,全球已有20余个国家或组织制定了生物类似药相关指南,以建立明确的生物类似药上市审批途径,既保证患者能及时得到这些生物制品,又能确保这些生物制品的质量、有效性和安全性。本文通过对生物治疗药物研发特点及国内外生物类似药研究进展进行综述,以帮助临床合理安全使用。
[Abstract]:Biotherapeutic drugs have been widely used in various fields of disease treatment. With the expiration of patents and data protection for early biological products, There has been a wave of biosimilarsdevelopment in the world. Biological analogues are similar to bioanalogues in terms of quality, safety and effectiveness. Because biologically similar drugs can better meet the public demand for biotherapy products, it can help to improve the accessibility and reduce the price of biopharmaceuticals, on the other hand, Because of the uniqueness and complexity of biotherapeutic drugs, Biological analogues cannot be exactly the same as those originally developed. The evaluation principles and regulations for "chemically generic drugs" do not apply to biological analogous drugs. Many countries attach great importance to the development and management of biological analogous drugs. More than 20 countries or organizations around the world have developed guidelines for the approval of biological-like drugs, in order to establish a clear approval path for the marketing of biomedical products, which can ensure that patients can obtain these biological products in a timely manner and ensure the quality of these biological products. This article reviews the research and development of biotherapeutic drugs and the research progress of biomedical analogues at home and abroad in order to help the rational and safe use of biotherapeutic drugs.
【作者单位】：北京协和医学院中国医学科学院肿瘤医院;
【分类号】：R945

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