...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Biologics: Targets and Therapy >A practical guide about biosimilar data for health care providers treating inflammatory diseases
【24h】

A practical guide about biosimilar data for health care providers treating inflammatory diseases

机译：有关生物相似性数据的实用指南，供医疗保健提供者治疗炎症性疾病

获取原文
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

To make informed decisions about the safety, efficacy, and clinical utility of a biosimilar, health care providers should understand the types and be able to analyze data generated from a biosimilar development program. This article reviews the biosimilar guidelines, the biosimilar development process to provide education and context about biosimilarity, and uses examples from infliximab biosimilars to review the terminology and potential types of analyses that may be used to compare potential biosimilars to the originator biologic. A biosimilar is a biologic product that is highly similar to an approved (originator) biologic, notwithstanding minor differences in clinically inactive components, and with no clinically meaningful differences in terms of the safety, purity, and potency of the product. Due to their complex nature and production in living systems, it is not possible to exactly duplicate the approved originator biologic. To ensure biosimilars provide consistent, safe, and effective treatment comparable to the originator biologic, extensive analyses of the potential biosimilar are conducted, including side-by-side analytical, nonclinical, and clinical comparisons. A key goal is to determine whether there are sufficient relevant similarities in chemical composition, biologic activity, and pharmacokinetic aspects between the potential biosimilar and the originator. Regulatory approvals and marketing authorizations for biosimilars are made on a case-by-case and agency-by-agency basis after evaluating the totality of the evidence generated from the entire development program. Understanding how regulatory agencies review data for approval can help health care providers make appropriate decisions when biosimilars become available for use in the treatment of inflammatory diseases, and therefore they should review the literature to gain further information about specific biosimilars.
机译：为了就生物仿制药的安全性，有效性和临床实用性做出明智的决定，医疗保健提供者应了解其类型并能够分析从生物仿制药开发计划中产生的数据。本文回顾了生物仿制药指南，生物仿制药的开发过程，以提供有关生物相似性的教育和背景信息，并使用英夫利昔单抗生物仿制药中的示例来审查可用于将潜在生物仿制药与原始生物仿制药进行比较的术语和潜在分析类型。生物仿制药是一种生物产品，与经过批准的（原产地）生物仿制药高度相似，尽管在临床上无活性的成分方面存在细微的差异，在产品的安全性，纯度和效力方面也没有临床上有意义的差异。由于其复杂的性质和在生命系统中的生产，因此不可能精确复制批准的原始生物。为确保生物仿制药能够提供与原始生物仿制药相当的一致，安全和有效的治疗方法，对潜在的生物仿制药进行了广泛的分析，包括并排分析，非临床和临床比较。一个关键目标是确定潜在的生物仿制药和原药之间在化学组成，生物学活性和药代动力学方面是否有足够的相似性。在评估了整个开发计划产生的全部证据之后，逐案和逐个机构地取得了生物仿制药的监管批准和市场许可。了解监管机构如何审查数据以获取批准可以帮助医疗保健提供者在生物仿制药可用于治疗炎症性疾病时做出适当的决定，因此，他们应该审查文献以获取有关特定生物仿制药的更多信息。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号