Abstract
Biotechnology Law ReportVol. 31, No. 2 Regulatory Affairs—PharmaceuticalFDA Releases Program for Approval of BiosimilarsDOCUMENT: Draft Guidance for Industry from FDA: Scientific Considerations in Demonstrating Biosimilarity to a Reference ProductDOCUMENT: Draft Guidance for Industry from FDA: Quality Considerations in Demonstrating Biosimilarity to a Reference Protein ProductPublished Online:4 May 2012https://doi.org/10.1089/blr.2012.9905AboutSectionsPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail FiguresReferencesRelatedDetailsCited byThe Emerging Treatment Landscape of Inflammatory Bowel Disease: Role of Innovator Biologics and Biosimilars11 December 2018 | EMJ GastroenterologyThe End of Phase 3 Clinical Trials in Biosimilars Development?26 June 2018 | BioDrugs, Vol. 32, No. 4Are We Ready for Biosimilars in Gastroenterology?14 December 2017 | EMJ GastroenterologyBiosimilars: Shaping the Future of Haematology28 July 2016 | EMJ HematologyBiologic Therapies: From Complexity to Clinical Practice in a Changing Environment15 December 2015 | EMJ GastroenterologyWill Biosimilars Change the Treatment Paradigm in Psoriasis?15 November 2015 | EMJ DermatologyThe Mobile Health Revolution?SSRN Electronic JournalOpening the Industry Playbook: Myths and Truths in the Debate Over BPA RegulationSSRN Electronic Journal Volume 31Issue 2Apr 2012 InformationCopyright 2012, Mary Ann Liebert, Inc.To cite this article:FDA Releases Program for Approval of BiosimilarsDOCUMENT: Draft Guidance for Industry from FDA: Scientific Considerations in Demonstrating Biosimilarity to a Reference ProductDOCUMENT: Draft Guidance for Industry from FDA: Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product.Biotechnology Law Report.Apr 2012.142-143.http://doi.org/10.1089/blr.2012.9905Published in Volume: 31 Issue 2: May 4, 2012PDF download
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