白皮书:美国生物仿制药市场与欧洲同步

IF 0.3 Q4 PHARMACOLOGY & PHARMACY

GaBI Journal-Generics and Biosimilars Initiative Journal Pub Date : 2020-12-15 DOI:10.5639/GABIJ.2020.0904.025

M. Feldman, M. Reilly

{"title":"白皮书:美国生物仿制药市场与欧洲同步","authors":"M. Feldman, M. Reilly","doi":"10.5639/GABIJ.2020.0904.025","DOIUrl":null,"url":null,"abstract":"In the US, 28 biosimilars have been approved, with 10 in the last two years. The US is keeping pace with the EU who pioneered biosimilars approvals a decade earlier. Herein, current FDA regulations and hurdles encountered for US biosimilar approval and uptake are discussed.","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":"32 1","pages":""},"PeriodicalIF":0.3000,"publicationDate":"2020-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":"{\"title\":\"A white paper: US biosimilars market on pace with Europe\",\"authors\":\"M. Feldman, M. Reilly\",\"doi\":\"10.5639/GABIJ.2020.0904.025\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"In the US, 28 biosimilars have been approved, with 10 in the last two years. The US is keeping pace with the EU who pioneered biosimilars approvals a decade earlier. Herein, current FDA regulations and hurdles encountered for US biosimilar approval and uptake are discussed.\",\"PeriodicalId\":43994,\"journal\":{\"name\":\"GaBI Journal-Generics and Biosimilars Initiative Journal\",\"volume\":\"32 1\",\"pages\":\"\"},\"PeriodicalIF\":0.3000,\"publicationDate\":\"2020-12-15\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"GaBI Journal-Generics and Biosimilars Initiative Journal\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.5639/GABIJ.2020.0904.025\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"GaBI Journal-Generics and Biosimilars Initiative Journal","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.5639/GABIJ.2020.0904.025","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}

引用次数: 1

摘要

在美国，已有28种生物仿制药获得批准，其中10种是在过去两年获得批准的。美国正在跟上欧盟的步伐，后者在10年前率先批准了生物仿制药。本文讨论了当前FDA法规和美国生物类似药批准和吸收遇到的障碍。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

A white paper: US biosimilars market on pace with Europe

In the US, 28 biosimilars have been approved, with 10 in the last two years. The US is keeping pace with the EU who pioneered biosimilars approvals a decade earlier. Herein, current FDA regulations and hurdles encountered for US biosimilar approval and uptake are discussed.

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

GaBI Journal-Generics and Biosimilars Initiative Journal PHARMACOLOGY & PHARMACY-

CiteScore

1.80

自引率

0.00%

发文量

期刊介绍： The scope of GaBI Journal is broad and of interest and relevance to professionals active in clinical practice, pharmaceutical science and policy. Materials published in GaBI Journal include high quality research reports, literature reviews and case studies, all of which are peer reviewed. Manuscripts on all aspects of generic and biosimilar medicines, covering areas in clinical, fundamental, technical, manufacturing, bi-processing, economic and social aspects of pharmaceuticals and therapeutics are welcome. In addition, high quality work submitted in other formats, for example, scientific and evidence-based commentaries, may also be considered. In all cases, the emphasis is on quality, originality and knowledge contribution to those involved in health care. All manuscripts submitted to GaBI Journal are subject to a rigorous peer review process. GaBI Journal plans to be indexed in PubMed within two years, and that indexing will be retrospective. GaBI Journal is published quarterly from 2012. All articles are published in English.