Literature DB >> 21904318

Why an abbreviated FDA pathway for biosimilars is overhyped.

Henry I Miller.   

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Year:  2011        PMID： 21904318     DOI： 10.1038/nbt.1960

Source DB:  PubMed          Journal:  Nat Biotechnol        ISSN： 1087-0156            Impact factor:   54.908


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  2 in total

Review 1.  The FDA's assessment of follow-on protein products: a historical perspective.

Authors:  Janet Woodcock; Joseph Griffin; Rachel Behrman; Barry Cherney; Terrie Crescenzi; Blair Fraser; Dena Hixon; Christopher Joneckis; Steven Kozlowski; Amy Rosenberg; Lewis Schrager; Emily Shacter; Robert Temple; Keith Webber; Helen Winkle
Journal:  Nat Rev Drug Discov       Date:  2007-06       Impact factor: 84.694

2.  Developing the nation's biosimilars program.

Authors:  Steven Kozlowski; Janet Woodcock; Karen Midthun; Rachel Behrman Sherman
Journal:  N Engl J Med       Date:  2011-08-04       Impact factor: 91.245
  2 in total

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