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Biosimilars/Subsequent Entry Biologics: Innova9ons and Challenges Michael S. Reilly, Esq. Executive Director, Alliance for Safe Biologic Medicines Presented at the Expert Patient Advocates & 21st Century Therapies Forum November 19, 2015 Toronto, ON

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Page 1: Michael reilly toronto nov19presentation final

Biosimilars/Subsequent  Entry  Biologics:  Innova9ons  and  Challenges  

Michael S. Reilly, Esq. Executive Director, Alliance for Safe Biologic Medicines

Presented at the Expert Patient Advocates & 21st Century Therapies Forum November 19, 2015

Toronto, ON

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About  The  Alliance  for  Safe  Biologic  Medicines  (ASBM)  

Harry  L.  Gewanter,  MD,  FAAP,  FACR:  Chairman,  pediatric  rheumatologist    

Philip  Schneider:  Dean,  University  of  Arizona  College  of  Pharmacy-­‐  Advisory  Board  Chair  Michael  Reilly,  ExecuJve  Director  [email protected]  

•  Steering  CommiMee  composed  of  paJent  and  physician  groups.  

•  Advisory  Board  of  physicians,    researchers,  pharmacists,  and  paJents.  

2

STEERING COMMITTEE

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“The  Four  Pillars”  

PRIORITIZING PATIENT ���SAFETY

LEVERAGING WHAT WE HAVE

LEARNED

PROMOTING PHARMACO-VIGILANCE

KEEPING ���HEALTHCARE PROVIDERS RELEVANT

ASBM’S GUIDING PRINCIPLES

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 Biologic  vs.  Chemical  Medicines  SIZE:  significantly  larger,  potenJal  for  immunogenic  reacJons  

STRUCTURE:  more  complex,  cannot  be  completely  characterized  or  copied  

STABILITY:  suscepJble  to  light,  heat,  denaturing  /  degradaJon  

SENSITIVITY:  even  small  manufacturing  changes  can  cause  changes  in  efficacy  and/or  adverse  effects  

DRIFT:  can  change  with  Jme  

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Biosimilars/SEBs:  A  Medical  Innova9on    

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Benefits  of  Biosimilars/SEBs  for  Pa9ents  

•  Increased  therapeuJc  opJons  

–  More  treatment  choices  for  physician  and  paJent.    

•  Cost  savings  over  reference  biologics:  

–  Unlike  generics,  which  save  40-­‐80%,  due  to  higher  development  costs  biosimilars  are  expected  to  save  payers  15-­‐30%1    

1. Generics and Biosimilars Initiative Journal (GaBI Journal). 2012;1(3-4).120-6. DOI: 10.5639/gabij.2012.0103-4.036

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Challenges  of  Bringing  Biosimilars  to  Pa9ents  

•  FDA’s  Dr.  Janet  Woodcock,  spoke  this  week  regarding  the  challenges  of  introducing  biosimilars,  saying:    "There  will  be  a  phase  [in]  of  acceptance,  or  perhaps,  partly  rejec9on,  from  the  medical  community,”    

•  Success  will  be  related  to  the  degree  of  physician  comfort  with  biosimilars.    

Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) at the U.S. (FDA)

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Building  Physician  Confidence  

•  ASBM  has  engaged  with  the  physician  community  through  surveys  and  ConJnuing  EducaJon  courses.    

•  Goal:  to  build  physician  confidence  in  biosimilars,  so  that  physicians  can  confidently  prescribe,  or  switch  paJents  to  biosimilars.    

•  However,  recogniJon  of  the  differences  between  biosimilars  and  generics  have  resulted  in  physician  cauJon  regarding  biosimilar  adopJon.  

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Gathering  the  Perspec9ves  of  Biologic  Prescribers  Around  the  World  

 U.S.  Physician  Surveys    (September  2012):  376  physicians  (February  2015):  400  physicians  (Labeling)  (November  2015*):  400  physicians      

E.U.  (France,  Italy,  Spain,  UK)    Physician  Survey  (November  2013):  470  physicians    

Canadian  Physician  Survey      (December  2014):  427  physicians  

U.S.  Pharmacist  Survey  (September  2015)  401  pharmacists  

La9n  America  (Argen9na,  Brazil,  Colombia,  Mexico)  Physician  Survey    (May  2015):  399  physicians  

All  surveys  available  at  www.SafeBiologics.org    

*Tena9ve  release  date  

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November  2014:  Presented  European  Survey  Data  to  Spanish  Health  Ministry    December  2014:  Presented  Canadian  Physician  Survey  data  to  Health  Canada  

May  19,  2015:  Shared  U.S.  data  and  recommendaJons  with  U.S.  Dept.  of  Health  and  Human  Services  and  other  AdministraJon  officials    April  13,  2015:  ParJcipated  in  60th  WHO  ConsultaJon  on  InternaJonal  Nonproprietary  Names  (INN)  

June  2015:  ParJcipated  in  WHO  Frontpage  MeeJng  to  finalize  the  Biologic  Qualifier  (BQ)  proposal.  

October  13:  ParJcipated  in  the  61th  WHO  INN  ConsultaJon    

October  14:  Presented  LaJn  American  survey  data  at  BIO  LaJn  America  Conference  in  Brazil    

 

 

 

Recent  ASBM  AcCvity  Sharing  Findings  with  Na9onal  and  Interna9onal  Regulators  

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Issues  Regulators  Need  to  Address  •  Assess  need  for  clinical  data,  as  it  relates  to  approval  and  

indicaJon  extrapolaJon.    

•  What  data  do  physicians  want  to  see  in  order  to  feel  comfortable  prescribing?    –  Physicians  want  informaJon  not  only  on  adverse  events,  

but  data  which  demonstrate  successful  clinical  use  of  biosimilars  (post-­‐market  data)    

•  Assurance  of  transparency,  in  naming  and  labeling-­‐  what  the  product  is  and  how  it  became  approved.    

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PHYSICIAN  SURVEY  FINDINGS      

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Indica9on  Extrapola9on:  A  Key  Concern  

80%  of  physicians  considered  it  important  for  label  to  show  whether  approval  for  an  indicaJon  was  based  on  DATA  or  EXTRAPOLATION:    

•  ExtrapolaJon  remains  a  concern  for  physicians  and  paJent  groups.  

•  Both  want  some  assurances  that  clinical  data  used  for  one  disease  area  can  be  applied  to  demonstrate  efficacy  in  another.    

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Recent  ASBM  AcCvity  Timeline:  Biologic  Naming  •  July  2014:  WHO  Proposes  its  “Biological  

Qualifier”-­‐  a  4-­‐leMer  code  to  disJnguish  similar  biologics  from  each  other.      www.who.int  

•  August  2015:  U.S.  Food  and  Drug  AdministraJon  (FDA)  issues  Guidance  supporJve  of  and  compaJble  with  WHO’s  BQ.    www.fda.gov  

•  Both  call  for  similar  biologics  (including  biosimilars)  to  have  a  shared  root  name  (InternaJonal  Nonproprietary  Name/  INN)  followed  by  a  four-­‐leMer  suffix.    

•  Health  Canada  has  been  generally  supporJve  of  the  WHO  approach.  

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Widespread  Physician  Support  for  Dis9nguishable  Naming  

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94%  of  La9n  American  Physicians  consider  WHO’s  BQ  Proposal  to  be  “useful”  in  helping  pa9ents  receive  the  correct  medicine.  

79%  of  Canadian  physicians  support  Health  Canada  issuing  dis9nct  names.  

66%  of  US  physicians  (and  68%  of  US  pharmacists)  support  FDA  issuing  dis9nct  names.  

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Pharmacy-­‐Level  Subs9tu9on:    A  Global  Challenge  

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How  Important  is  No9fica9on  of  a  Biosimilar  Subs9tu9on?  

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87%  of  La9n  American  Physicians  consider  it  “very  important”  or  “cri9cal”  

85%  of  Canadian  consider  it  “very  important”  or  “cri9cal”  

80%  of  US  physicians  consider    it  “very  important”  or  “cri9cal”    

77%  of  EU  Physicians  consider  it  “very  important”    or  “cri9cal”  

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Importance  to  Pa9ents    

•  PaJent  always  needs  to  be  informed  about    the  medicine  he/she  is  receiving  in  order  to    make  informed  choices  and  be  an  effecJve    partner  in  care.  

•  Physician  needs  to  be  aware  of  what    medicine  paJent  is  receiving  to  provide    proper  care.    

•  Accurate  paJent  record  must  be  kept  for  pharmacovigilance/post-­‐market  monitoring  for  adverse  events  and  efficacy  

•  Physicians  and  pharmacists  have  a  responsibility  to  the  paJent  and  to  the  larger  community  (other  healthcare  providers,  regulators,  manufacturers)  to  work  collaboraJvely  together  –  that  includes  clear,  Cmely  communicaCon.    

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Transparency  in  Labeling:    An  Emerging  Issue  

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March  6:  First  Biosimilar  Approved  in  U.S.    

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Reference ID: 3711895

•  Zarxio  (filgras9m-­‐sndz)  

•  Went  on  sale  September  3.  

•  15%  discount  over  reference  product  

•  Not  “interchangeable”  

Page 22: Michael reilly toronto nov19presentation final

22  

Concerns  Surrounding  Biosimilar  Labeling  Some  concerns  surrounding  insufficient  transparency  in  Zarxio’s  labeling:  

•  It  is  not  idenJfied  as  a  biosimilar.  

•  No  data  used  to  demonstrate  biosimilarity  is  included.  

•  Not  specified  for  which  indicaJons  approval  was  based  on  trial  data,  or  extrapolaJon.  

•  Data  from  innovator  product    is  not  idenJfied  as  such.  

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Reference ID: 3711895

Page 23: Michael reilly toronto nov19presentation final

What  Do  Physicians  Want  to  See  on  a  Biosimilar  Label?  

23

These  items  were  consistently  rated  a  “4”  or  a  “5”-­‐  indicaJng  high  or  very  high  importance  in  a  February  2015  Survey  of  400  U.S.  physicians:        90%  -­‐  That  product  is  a  biosimilar      79%  -­‐  A  definiJon  of  biosimilarity      82%  -­‐  AnalyJcal  data  used  by  biosimilar  sponsor  to  demonstrate  its  similarity  to  its  reference  product      83%  -­‐  Clinical  data  used  to  demonstrate  biosimilar  is  highly  similar  to  reference  product      79%  -­‐  Post-­‐market  surveillance  data  on  the  biosimilar      77%  -­‐  Name  of  the  biosimilar's  reference  product      79%  -­‐  IndicaJons  for  which  the  originator  is  approved,  but  the  biosimilar  is  not      79%  -­‐  Clear  disJnguishable  reference  product  data  from  biosimilar  data      79%  -­‐  Clinical  similarity  data  including  immunogenicity  effects      80%  -­‐  Which  approved  indicaJons  were  actually  studied,  vs.  which  were  extrapolated  from  data  in  other      indicaJons?      79%  -­‐  Whether  or  not  the  biosimilar  is  "interchangeable"  with  its  reference  product    

Page 24: Michael reilly toronto nov19presentation final

Summary  

24

•  Building  physician  confidence  is  essenJal  in  order  to  bring  the  innovaJons  of  biosimilars  to  paJents.    

•  Physicians  worldwide  support  the  use  of  disJnguishable  names  for  biologic  products.    

•  In  the  event  of  a  biosimilar  subsJtuJon,  physicians  worldwide  consider  it  very  important  to  know  the  exact  medicine  their  paJent  receives.    

•  Transparency  in  labeling  also  helps  providers  make  informed  decisions  and  promotes  confidence  in  biosimilars.  IndicaJon  extrapolaJon  is  of  parJcular  concern.    

Page 25: Michael reilly toronto nov19presentation final

Thank  You  For  Your  Apen9on