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Title:           The ‘totality of evidence’ and ‘extrapolation’ of SB17, a ustekinumab biosimilar
Keywords:        Biosimilar; crohn’s disease; psoriasis; psoriatic arthritis; SB17; totality of evidence; ulcerative colitis; ustekinumab
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     Item: 
      Title: Abstract
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     Item: 
      Title: 1.  Introduction
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     Item: 
      Title: 2.  Totality of evidence in SB17 development
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      Children: 
       Item: 
        Title: 2.1.  Evidence-based approach to support biosimilarity
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       Item: 
        Title: 2.2.  Analytical characterization
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       Item: 
        Title: 2.3.  Non-clinical invivo evidence
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       Item: 
        Title: 2.4.  Phase Iclinical study
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       Item: 
        Title: 2.5.  Phase III clinical study
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     Item: 
      Title: 3.  Immunogenicity of UST biosimilars
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        Title: 3.1.  Immunogenicity and clinical implications
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        Title: 3.2.  SB17 manufacturing differences and quality attributes
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      Title: 4.  Extrapolation of SB17 clinical data across indications
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        Title: 4.1.  Regulatory basis for extrapolation
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        Title: 4.2.  Mechanism of action and extrapolated indications of SB17
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       Item: 
        Title: 4.3.  Primary indication of psoriasis for ustekinumab and SB17 evaluations
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        Title: 4.4.  Interchangeability of ustekinumab biosimilars
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      Title: 5.  Further convenience of SB17
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        Title: 5.1.  Device features of SB17 and ustekinumab reference product
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       Item: 
        Title: 5.2.  Extended stability and enhanced flexibility of the SB17 pre-filled syringe
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      Title: 6.  Conclusions
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     Item: 
      Title: 7.  Expert opinion
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      Title: Funding
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      Title: Declaration of interest
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      Title: Author contributions
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     Item: 
      Title: Acknowledgments
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     Item: 
      Title: References
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  Checksum: b9df2976
   Type: CRC32
  Checksum: 7deb25f9463bed1410f5149fe4367d1e
   Type: MD5
  Checksum: 4d66c638120aada9a2346affb3dfc7cd42a36858
   Type: SHA-1
  Checksum: 7d35712cfe3ca9670f8cac11ab655e0821d487de2c3dd80f1698a6bdc569fa8a
   Type: SHA-256