美国和欧洲生物类似药的发展（英文）

发布时间：2018-02-22 22:43

本文关键词： 生物类似药的研发监管指导原则欧洲药品管理局指导原则美国食品药品管理局指导原则证据链完备性生物相似性　出处：《药物分析杂志》2015年05期 　论文类型：期刊论文

【摘要】：生物类似药(biosimilars)是与已批准上市的生物制品高度相似的药物,与小分子仿制药物(generics)不同,生物类似药并不是他们参比制品的精确复制品。尽管高度相似,生物类似药在某些方面仍然可能与参比制品不同,生物类似药间也会互不相同。生物制品不仅由于其复杂的性质和生产过程,还由于存在独特的免疫原性和活性的安全隐患,给研发和监管带来了相当大的挑战。欧洲药品管理局和美国食品药品管理局的指导原则建议采用"证据链完备性"(totality-of-evidence)的方法全面覆盖生物类似药物开发的各个步骤,包括分析表征化、结构相似性和功能等效性等的证据。这种"证据链完备性"是生物类似药整个研发过程中其余工作的基石,包括必须的动物试验研究、人体药代动力学/药效学研究,以及至少1个临床研究,以证实生物类似药功效等效,并且免疫原性或安全性风险没有增加。临床研究应选择敏感人群来进行试验,以便发现任何有临床意义的差异。工艺稳定质量恒定的生物类似药的研发需要丰富的经验和专业技能,只有这样才能够确保患者得到良好治疗。
[Abstract]:Bioanalogs are highly similar to approved biological products, unlike small molecular mimics, which are not exact replicas of their reference products. Biological analogues may still be different from reference products in some respects, and may differ from each other because of their complex properties and production processes, but also because of the unique safety risks of immunogenicity and activity. The guidelines of the European Drug Administration and the United States Food and Drug Administration recommend the adoption of a "chain of evidence" approach that fully covers all steps in the development of bioanalogous drugs. Including evidence for analysis of representativeness, structural similarity and functional equivalence. This "chain of evidence completeness" is the cornerstone of the rest of the work throughout the development of biomedical analogues, including the necessary animal experimental research, Human pharmacokinetics / pharmacodynamics studies, as well as at least one clinical study, to prove that bioanalogous drugs are equivalent and that there is no increased risk of immunogenicity or safety. Clinical studies should select sensitive populations for trials, In order to find any differences of clinical significance, the development of biological similar drugs with stable process and constant quality requires rich experience and professional skills to ensure that patients are well treated.
【作者单位】： Biosimilars
【分类号】：R95

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