炎症性肠病的生物相似性互换性和新出现的治疗策略:综述

IF 1.5 Q3 GASTROENTEROLOGY & HEPATOLOGY Gastroenterology Insights Pub Date : 2021-06-24 DOI:10.3390/gastroent12030026
R. Parrish
{"title":"炎症性肠病的生物相似性互换性和新出现的治疗策略:综述","authors":"R. Parrish","doi":"10.3390/gastroent12030026","DOIUrl":null,"url":null,"abstract":"This commentary summarizes a collection of key references published within the last ten years, and identifies pharmacologic research directions to improve treatment access and success through greater biosimilar or “follow-on” biologic utilization combined with other targeted small molecule agents that possess unique pathophysiologic mechanisms for inflammatory bowel diseases (IBD) in adult and pediatric patients. Since they are not identical to the originator or reference biologic agent, all biosimilars are not generically equivalent. However, in the US and other countries, they are considered therapeutically interchangeable if the manufacturer has demonstrated no clinically meaningful differences from the reference product. Comparisons of different clinical initiation and switching scenarios are discussed with reference to interchangeability, immunogenicity, nocebo effect, cost effectiveness, and time courses for discontinuation rates.","PeriodicalId":43586,"journal":{"name":"Gastroenterology Insights","volume":"28 1","pages":""},"PeriodicalIF":1.5000,"publicationDate":"2021-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.3390/gastroent12030026","citationCount":"0","resultStr":"{\"title\":\"Biosimilar Interchangeability and Emerging Treatment Strategies for Inflammatory Bowel Diseases: A Commentary\",\"authors\":\"R. Parrish\",\"doi\":\"10.3390/gastroent12030026\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"This commentary summarizes a collection of key references published within the last ten years, and identifies pharmacologic research directions to improve treatment access and success through greater biosimilar or “follow-on” biologic utilization combined with other targeted small molecule agents that possess unique pathophysiologic mechanisms for inflammatory bowel diseases (IBD) in adult and pediatric patients. Since they are not identical to the originator or reference biologic agent, all biosimilars are not generically equivalent. However, in the US and other countries, they are considered therapeutically interchangeable if the manufacturer has demonstrated no clinically meaningful differences from the reference product. Comparisons of different clinical initiation and switching scenarios are discussed with reference to interchangeability, immunogenicity, nocebo effect, cost effectiveness, and time courses for discontinuation rates.\",\"PeriodicalId\":43586,\"journal\":{\"name\":\"Gastroenterology Insights\",\"volume\":\"28 1\",\"pages\":\"\"},\"PeriodicalIF\":1.5000,\"publicationDate\":\"2021-06-24\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.3390/gastroent12030026\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Gastroenterology Insights\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.3390/gastroent12030026\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"GASTROENTEROLOGY & HEPATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Gastroenterology Insights","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.3390/gastroent12030026","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
引用次数: 0

摘要

本评论总结了过去十年中发表的主要参考文献,并确定了药理学研究方向,通过更多的生物仿制药或“后续”生物利用与其他靶向小分子药物相结合来提高治疗的可及性和成功率,这些药物对成人和儿童患者的炎症性肠病(IBD)具有独特的病理生理机制。由于它们与原始生物制剂或参考生物制剂不相同,因此所有生物仿制药在一般意义上都不等同。然而,在美国和其他国家,如果制造商证明与参考产品没有临床意义的差异,则认为它们在治疗上是可互换的。讨论了不同临床启动和转换方案的比较,包括互换性、免疫原性、nocebo效应、成本效益和停药率的时间过程。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
Biosimilar Interchangeability and Emerging Treatment Strategies for Inflammatory Bowel Diseases: A Commentary
This commentary summarizes a collection of key references published within the last ten years, and identifies pharmacologic research directions to improve treatment access and success through greater biosimilar or “follow-on” biologic utilization combined with other targeted small molecule agents that possess unique pathophysiologic mechanisms for inflammatory bowel diseases (IBD) in adult and pediatric patients. Since they are not identical to the originator or reference biologic agent, all biosimilars are not generically equivalent. However, in the US and other countries, they are considered therapeutically interchangeable if the manufacturer has demonstrated no clinically meaningful differences from the reference product. Comparisons of different clinical initiation and switching scenarios are discussed with reference to interchangeability, immunogenicity, nocebo effect, cost effectiveness, and time courses for discontinuation rates.
求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Gastroenterology Insights
Gastroenterology Insights GASTROENTEROLOGY & HEPATOLOGY-
CiteScore
2.80
自引率
3.40%
发文量
35
审稿时长
10 weeks
期刊最新文献
Correlation between Interleukin-17, High Sensitivity C-Reactive Protein and Pepsinogen in Helicobacter pylori Infected Gastritis Elevated Incidence and Risk of Emergent Cirrhosis Complications in Alcoholic Cirrhosis Compared with Other Etiologies Insights into the Characteristics and Functions of Mast Cells in the Gut Terlipressin for the Prevention and Treatment of Renal Decline in Hepatorenal Syndrome: A Drug Profile. Microbiome and Genetic Factors in the Pathogenesis of Liver Diseases
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1