EU: Biosimilars – A Success Story!
EU Regulatory Framework

–  In	
  place	
  since	
  2006	
  and	
  further	
  
expanded...
EU: Revision of Overarching
Guidelines for Biosimilars (1)
Additional guidance in five main areas

–  Risk-­‐based	
  appr...
EU: Revision of Overarching
Guidelines for Biosimilars (2)
Sourcing of reference product:

–  Use	
  of	
  reference	
  pr...
USA: Biosimilars – When does the
Story start?
Legal pathway in the US for the approval of biosimilars:

–  Biologics	
  Pr...
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EU: Biosimilars – A Success Story! Pharma Integrates 2013

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EU: Biosimilars – A Success Story!
A presentation by Conrad Savoy at Pharma Integrates 2013, an event for senior management in the pharmaceutical industry created and run by Life Sciences Index.

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EU: Biosimilars – A Success Story! Pharma Integrates 2013

  1. 1. EU: Biosimilars – A Success Story! EU Regulatory Framework –  In  place  since  2006  and  further   expanded   –  Product  class  specific  guidelines   developed   –  Immunogenicity  guidelines   –  Overarching  guidelines  presently     under  revision       Ø  17  biosimilars  authorized  (2  MAbs)   Ø  Learning  Insights   Ø  «Case  by  case  decision»   Ø  «Stepwise  approach»       Copyright  ©  2013    Conrad  SAVOY,  PhD,  MBA      conradsavoy@hotmail.com       1
  2. 2. EU: Revision of Overarching Guidelines for Biosimilars (1) Additional guidance in five main areas –  Risk-­‐based  approach  for  the  design  of   non-­‐clinical  studies   –  Use  of  PD  markers  in  support  of  clinical   comparability   –  Efficacy  trial  design  (non-­‐inferiority   versus  equivalence)   •  Choice  of  an  appropriate  pa[ent  popula[on   •  Choice  of  surrogate  endpoints   –  Design  of  immunogenicity  studies   –  Extrapola[on  of  efficacy  and  safety   from  one  therapeu[c  indica[on  to   another   Copyright  ©  2013    Conrad  SAVOY,  PhD,  MBA    conradsavoy@hotmail.com       2
  3. 3. EU: Revision of Overarching Guidelines for Biosimilars (2) Sourcing of reference product: –  Use  of  reference  products   sourced  from  highly  regulated   markets  outside  of  Europe   –  Revised  dra  guideline  is  an   important  step  toward  global   development  of  biosimilars:   •  Avoid  repeat  clinical  trials  which   do  not  serve  any  scien[fic   purpose  (unethical)   •  Limit  development  costs  for   biosimilars  of  >  EUR  100  -­‐  200   which  otherwise  would  almost   double   Copyright  ©  2013    Conrad  SAVOY,  PhD,  MBA    conradsavoy@hotmail.com       3
  4. 4. USA: Biosimilars – When does the Story start? Legal pathway in the US for the approval of biosimilars: –  Biologics  Price  Compe[[on  and  Innova[on   Act  (BPCI  Act)  of  2009   –  The  BPCI  Act  signed  into  law  on  23  March   2010     –  The  BPCI  Act  establishes  an  abbreviated   approval  pathway  for  biological  products   ‘highly  similar’  (biosimilar)  to,  or   ‘interchangeable’  with,  an  FDA  approved   biological  product     –  FDA  has  yet  to  issue  finalized  prac[cal   guidance  (dra  guidance  2/2012  &  3/2013)   –  Three  years  down  the  line  FDA  is  s[ll   awai[ng  its  first  biosimilar  applica[on   Copyright  ©  2013    Conrad  SAVOY,  PhD,  MBA    conradsavoy@hotmail.com       4

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