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David C. Dale

: Health Canada ; 2008 . 44 Dudzinski DM Kesselheim AS . Scientific and legal viability of follow-on protein drugs . N Engl J Med 2008 ; 358 : 843 – 849 . 45 Pollock C Johnson DW Hörl WH . Pure red cell aplasia induced by

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Bradford R. Hirsch and Gary H. Lyman

characterizing biopharmaceuticals and the implications for biosimilars . Nat Rev Drug Discov 2012 ; 11 : 527 – 540 . 17. Woodcock J Griffin J Behrman R . The FDA’s assessment of follow-on protein products: a historical perspective . Nat Rev Drug