...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Journal of Internal Medicine >Biosimilars in immune-mediated inflammatory diseases: initial lessons from the first approved biosimilar anti-tumour necrosis factor monoclonal antibody
【24h】

Biosimilars in immune-mediated inflammatory diseases: initial lessons from the first approved biosimilar anti-tumour necrosis factor monoclonal antibody

机译：免疫介导的炎症性疾病中的生物仿制性：来自第一批准的生物仿生抗肿瘤坏死因子单克隆抗体的初始课程

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

The introduction of targeted biological therapies has revolutionised the management of immune-mediated inflammatory diseases (IMIDs) such as rheumatoid arthritis, ankylosing spondylitis, psoriasis and inflammatory bowel disease. Following treatment with these therapies, many patients experience significant improvements in different aspects of their disease, including symptoms, work productivity and other outcomes relevant for individuals and society. However, due to the complexity of biological drug development and manufacturing processes, the costs of these therapies are relatively high. Indeed, the financial burden on healthcare systems due to biological therapies is considerable and lack of patient access to effective treatment remains a concern in many parts of the world. As many reference biological therapies have now reached or are near to patent expiry, a number of biosimilar' drugs have been developed for use in various clinical settings, and some of these drugs are already in use in several countries. While the potential pharmacoeconomic benefits of cost-effective biosimilars seem clear, several issues have been raised regarding, for example, the definition of biosimilarity and the validity of indication extrapolation, as well as the switchability' and relative immunogenicity of biosimilars and their reference drugs. In this review, these issues will be discussed with reference to CT-P13, a biosimilar of the anti-tumour necrosis factor monoclonal antibody infliximab, which is approved in Europe and elsewhere for the treatment of various IMIDs. Other important issues, including those related to data collection during nonclinical and clinical development of biosimilars, are also discussed.
机译：靶向生物疗法的引入彻底改变了免疫介导的炎症疾病（IMID）的管理，如类风湿性关节炎，强直性脊柱炎，牛皮癣和炎症性肠病。在用这些疗法治疗后，许多患者在其疾病的不同方面经历了显着的改善，包括对个人和社会相关的症状，工作生产力和其他结果。然而，由于生物药物开发和制造过程的复杂性，这些疗法的成本相对较高。实际上，由于生物疗法导致医疗保健系统的财务负担是相当大的，并且缺乏患者获得有效治疗的获得仍然是世界许多地区的关注。随着现在达到或靠近专利到期的较多参考生物疗法，已经开发了许多生物仿生的药物用于各种临床环境，其中一些药物已经在几个国家使用。虽然具有成本效益的生物仿制性的潜在药物经济效果似乎很清楚，但有几个问题已经提出了例如生物纤照的定义和指示外推的有效性，以及生物仿制性和其参考药物的可切换性“和相对免疫原性。在本文中，将参考欧洲和其他地方批准的抗肿瘤坏死因子单克隆抗体单克隆抗体inciximab的生物仿制性的CT-P13进行这些问题。还讨论了其他重要问题，包括与生物仿制物的非临床和临床开发期间与数据收集相关的问题。

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