Biosimilars pp 71-84 | Cite as

Biosimilars: Challenges Raised by Biosimilars: Who is Responsible for Cost and Risk Management?

  • F. MegerlinEmail author


A brief didactic point of view for non-specialists about the costs after the launching of biosimilars on the market european competitors’ (important market in value), payers’ (significant savings expected for all parties), at last doctors and pharmacists’. How costs are established, what savings may be expected, is there a liability specific to biosimilars? In this chapter, a quick comparative view of European and American approaches and the concept of interchangeability.


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Further Reading

  1. EMEA Workshop on Biosimilar Monoclonal Antibodies, 2 July 2009 – Session 3Google Scholar
  2. Age Biotech Come To (2006) Health Affairs 25:1202–1309CrossRefGoogle Scholar
  3. Schellenkens H (2009) Biosimilar therapeutics – what do we need to consider? Nephr. Diag. Trans 2:i27–i36Google Scholar
  4. Pisani J, Bonduelle Y (2008) Opportunities and Barriers in the Biosimilar Mar-ket : Evolution or Revolution for Generics Companies? PWC LondonGoogle Scholar
  5. Thompson Pharma’s Red Book 2007Google Scholar
  6. Bols T (2008) Biosimilar in Clinical Practice – the Challenges for Hospital Phar-macists. Journal of European Association of Hospital Pharmacists, vol 14(2):33–34Google Scholar
  7. Bols T, Biosimilars in Europe : from approval to clinical practice, Washington University, WDC, sept. 2008Google Scholar
  8. European Generic Medicine Association Handbook for biosimilars,
  9. Biosimilars Series: Stakeholder Analysis A Panoramic View of the Emerging Biosimilars Landscape (2008), DATA MONITOR DMHC 2426Google Scholar
  10. Cornes P (2011) The economic pressures for biosimilar drug use in cancer me-dicine. Oncologie, Springer-Verlag. doi: 10.1007/S10269-011-2017-9 Google Scholar
  11. Megerlin F, Lopert R, Trouvin JH Biosimilars and the European experience: implications for the United States (to be published in Health Affairs) Google Scholar

Copyright information

© Springer-Verlag France 2013

Authors and Affiliations

  1. 1.LIRAESUniversité Paris DescartesParisFrance

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