{"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":0,"journal":{"name":"","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"","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":"","JCRName":"","Score":null,"Total":0}
引用次数: 1
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.
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