生物仿制药时代的到来:个人观点

Sarfaraz K Niazi
{"title":"生物仿制药时代的到来:个人观点","authors":"Sarfaraz K Niazi","doi":"10.3390/biologics2020009","DOIUrl":null,"url":null,"abstract":"Biosimilars have come of age over the past 17 years, with 84 approvals in the EU and 35 in the US, representing almost 90% of the world market. While the acceptance of biosimilars in the US is catching up with that in the EU, the cost benefits remain elusive due to the high development barrier and complex distribution system involved, mainly in the US. In the EU, the cost of biosimilars has already dropped 70% or more, and interchangeability is a routine in some European jurisdictions, unlike in the US, where a separate regulatory approval is required. This paper projects significant changes coming in the US and EU’s biosimilars approval requirements that will impact the approval procedures in the rest of the world, leading to dramatic changes in the cost of biosimilars to patients. This perspective is based on the author’s first-hand experience to secure FDA approvals of biosimilars and an extensive analysis of the rationality of testing to demonstrate biosimilarity. Multiple citizen petitions by the author and meetings with the FDA may have prompted the recent announcement by the FDA to award a $5 million research grant to scientists to develop novel testing models to establish biosimilarity, including modifying the interchangeability protocols. Soon, demonstration of biosimilarity will not require animal testing and, in most cases, clinical efficacy testing; over time, the clinical pharmacology testing will be reduced as the regulatory agencies develop more confidence in the safety and efficacy of biosimilars. Biosimilars have come of age; now it is the turn of the developers to grow up, and one way to show this is to challenge the current regulatory guidelines but only on scientific grounds to seek more concessions, for which both FDA and EMA are ready.","PeriodicalId":93526,"journal":{"name":"Biologics (Basel, Switzerland)","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2022-04-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"14","resultStr":"{\"title\":\"The Coming of Age of Biosimilars: A Personal Perspective\",\"authors\":\"Sarfaraz K Niazi\",\"doi\":\"10.3390/biologics2020009\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Biosimilars have come of age over the past 17 years, with 84 approvals in the EU and 35 in the US, representing almost 90% of the world market. While the acceptance of biosimilars in the US is catching up with that in the EU, the cost benefits remain elusive due to the high development barrier and complex distribution system involved, mainly in the US. In the EU, the cost of biosimilars has already dropped 70% or more, and interchangeability is a routine in some European jurisdictions, unlike in the US, where a separate regulatory approval is required. This paper projects significant changes coming in the US and EU’s biosimilars approval requirements that will impact the approval procedures in the rest of the world, leading to dramatic changes in the cost of biosimilars to patients. This perspective is based on the author’s first-hand experience to secure FDA approvals of biosimilars and an extensive analysis of the rationality of testing to demonstrate biosimilarity. Multiple citizen petitions by the author and meetings with the FDA may have prompted the recent announcement by the FDA to award a $5 million research grant to scientists to develop novel testing models to establish biosimilarity, including modifying the interchangeability protocols. Soon, demonstration of biosimilarity will not require animal testing and, in most cases, clinical efficacy testing; over time, the clinical pharmacology testing will be reduced as the regulatory agencies develop more confidence in the safety and efficacy of biosimilars. Biosimilars have come of age; now it is the turn of the developers to grow up, and one way to show this is to challenge the current regulatory guidelines but only on scientific grounds to seek more concessions, for which both FDA and EMA are ready.\",\"PeriodicalId\":93526,\"journal\":{\"name\":\"Biologics (Basel, Switzerland)\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2022-04-20\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"14\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Biologics (Basel, Switzerland)\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.3390/biologics2020009\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Biologics (Basel, Switzerland)","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.3390/biologics2020009","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 14

摘要

在过去的17年里,生物仿制药已经成熟,欧盟批准了84个,美国批准了35个,几乎占世界市场的90%。虽然美国对生物仿制药的接受程度正在赶上欧盟,但由于开发障碍高,涉及复杂的分销系统,成本效益仍然难以捉摸,主要是在美国。在欧盟,生物仿制药的成本已经下降了70%或更多,而且在一些欧洲司法管辖区,可互换性是一种常规,不像在美国,需要单独的监管批准。本文预测美国和欧盟的生物仿制药审批要求将发生重大变化,这将影响世界其他地区的审批程序,导致患者的生物仿制药成本发生巨大变化。这种观点是基于作者的第一手经验,以确保FDA批准生物仿制药和广泛的分析测试的合理性,以证明生物相似性。作者的多次公民请愿和与FDA的会议可能促使FDA最近宣布向科学家提供500万美元的研究资助,以开发新的测试模型,以建立生物相似性,包括修改互换性协议。很快,证明生物相似性将不需要动物试验,在大多数情况下,不需要临床疗效试验;随着时间的推移,随着监管机构对生物仿制药的安全性和有效性越来越有信心,临床药理学测试将会减少。生物仿制药已经成熟;现在轮到开发人员成长了,一种方法是挑战当前的监管指导方针,但只在科学的基础上寻求更多的让步,这是FDA和EMA都准备好的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The Coming of Age of Biosimilars: A Personal Perspective
Biosimilars have come of age over the past 17 years, with 84 approvals in the EU and 35 in the US, representing almost 90% of the world market. While the acceptance of biosimilars in the US is catching up with that in the EU, the cost benefits remain elusive due to the high development barrier and complex distribution system involved, mainly in the US. In the EU, the cost of biosimilars has already dropped 70% or more, and interchangeability is a routine in some European jurisdictions, unlike in the US, where a separate regulatory approval is required. This paper projects significant changes coming in the US and EU’s biosimilars approval requirements that will impact the approval procedures in the rest of the world, leading to dramatic changes in the cost of biosimilars to patients. This perspective is based on the author’s first-hand experience to secure FDA approvals of biosimilars and an extensive analysis of the rationality of testing to demonstrate biosimilarity. Multiple citizen petitions by the author and meetings with the FDA may have prompted the recent announcement by the FDA to award a $5 million research grant to scientists to develop novel testing models to establish biosimilarity, including modifying the interchangeability protocols. Soon, demonstration of biosimilarity will not require animal testing and, in most cases, clinical efficacy testing; over time, the clinical pharmacology testing will be reduced as the regulatory agencies develop more confidence in the safety and efficacy of biosimilars. Biosimilars have come of age; now it is the turn of the developers to grow up, and one way to show this is to challenge the current regulatory guidelines but only on scientific grounds to seek more concessions, for which both FDA and EMA are ready.
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
自引率
0.00%
发文量
0
×
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
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
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 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信