Biosimilar Interchangeability and Emerging Treatment Strategies for Inflammatory Bowel Diseases: A Commentary

IF 1.5 Q3 GASTROENTEROLOGY & HEPATOLOGY Gastroenterology Insights Pub Date : 2021-06-24 DOI:10.3390/gastroent12030026
R. Parrish
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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.
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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
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。
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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
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