...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Drug Design, Development and Therapy >Ten years of clinical experience with biosimilar human growth hormone: a review of safety data
【24h】

Ten years of clinical experience with biosimilar human growth hormone: a review of safety data

机译：生物仿制人生长激素的十年临床经验：安全性数据综述

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

摘要

Safety concerns for recombinant human growth hormone (rhGH) treatments include impact on cancer risk, impact on glucose homeostasis, and the formation of antibodies to endogenous/exogenous GH. Omnitrope? (biosimilar rhGH) was approved by the European Medicines Agency in 2006, with approval granted on the basis of comparable quality, safety, and efficacy to the reference medicine (Genotropin?). Additional concerns that may exist in relation to biosimilar rhGH include safety in indications granted on the basis of extrapolation and the impact of changing to biosimilar rhGH from other rhGH treatments. A substantial data set is available to fully understand the safety profile of biosimilar rhGH, which includes data from its clinical development studies and 10 years of post-approval experience. As of June 2016, 106,941,419 patient days (292,790 patient-years) experience has been gathered for biosimilar rhGH. Based on the available data, there have been no unexpected or unique adverse events related to biosimilar rhGH treatment. There is no increased risk of cancer, adverse glucose homeostasis, or immunogenic response with biosimilar rhGH compared with the reference medicine and other rhGH products. The immunogenicity of biosimilar rhGH is also similar to that of the reference and other rhGH products. Physicians should be reassured that rhGH products have a good safety record when used for approved indications and at recommended doses, and that the safety profile of biosimilar rhGH is in keeping with that of other rhGH products.
机译：重组人类生长激素（rhGH）治疗的安全性问题包括对癌症风险的影响，对葡萄糖稳态的影响以及对内源性/外源性GH抗体的形成。 Omnitrope ？（生物类似药rhGH）于2006年获得了欧洲药品管理局的批准，并在与参考药物（Genotropin ？）。与生物仿制药rhGH有关的其他问题还包括根据外推法获得的适应症的安全性以及从其他rhGH处理转变为生物仿制药rhGH的影响。现有大量数据可充分了解生物仿制药rhGH的安全性，其中包括来自其临床开发研究的数据以及10年的批准后经验。截至2016年6月，已经收集了生物仿制药rhGH的106,941,419天患者日（292,790患者年）。根据现有数据，没有与生物仿制药rhGH治疗相关的意外或独特不良事件。与参考药物和其他rhGH产品相比，使用生物仿制药rhGH不会增加患癌症，不良葡萄糖体内稳态或免疫原性反应的风险。生物仿制药rhGH的免疫原性也与参考和其他rhGH产品的相似。应确保医师确保rhGH产品用于批准的适应症和推荐剂量时具有良好的安全记录，并且生物仿制药rhGH的安全性与其他rhGH产品保持一致。

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