{"title":"The Science of Biosimilars—Updating Interchangeability","authors":"Patrizia Cavazzoni, Sarah Yim","doi":"10.1001/jama.2024.15225","DOIUrl":null,"url":null,"abstract":"This Viewpoint from the US Food and Drug Administration (FDA) summarizes a recent update to an FDA draft interchangeability guidance regarding the need for clinical switching studies to illustrate the FDA’s ongoing efforts to streamline the development of biosimilar medications that are in line with the latest science.","PeriodicalId":518009,"journal":{"name":"JAMA","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"JAMA","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1001/jama.2024.15225","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
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Abstract
This Viewpoint from the US Food and Drug Administration (FDA) summarizes a recent update to an FDA draft interchangeability guidance regarding the need for clinical switching studies to illustrate the FDA’s ongoing efforts to streamline the development of biosimilar medications that are in line with the latest science.
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