title: Biosimilar versus patented erythropoietins: learning from 5 years of European and Japanese experience.
abstract: BACKGROUND
  Patent expiries on leading biologics are creating new momentum in the market for biosimilars (copies of off-patent biologics), paving the way for their development. However, little is known about the factors influencing the competition between biosimilars and their reference products (REF).
  
  
  OBJECTIVE
  The aim of this study was to analyse key global erythropoietin (EPO) markets and factors affecting biosimilar EPO (BIOSIM-EPO) uptakes, and to identify countries where BIOSIM-EPOs have gained significant market shares.
  
  
  METHODS
  Inclusion criteria for countries in the study were a biosimilar regulatory framework similar to the EU framework, and biological market value higher than US$2.5 billion. Factors evaluated included EPO market size, EPO retail/hospital distribution mix, national incentives to use biosimilars and BIOSIM-EPO/REF price differences. IMS Health provided EPO consumption in volumes, values, and EPO ex-manufacturer prices from 2007 to 2012.
  
  
  RESULTS
  Japan: large-sized market, mixed retail/hospital distribution, no incentives, low BIOSIM-EPO uptake (6.8 % in 2012). France: large-sized market, dominant retail distribution, no incentives, low BIOSIM-EPO uptake (5.8 %). Spain and Italy: medium-sized market, dominant hospital distribution, no incentives, moderate BIOSIM-EPO uptakes (11.5 and 8.6 %). Germany: small-sized market, dominant retail distribution, presence of incentives, high BIOSIM-EPO uptake (30.4 %). UK: small-sized market, mixed retail/hospital distribution, no incentives, low BIOSIM-EPO uptake (2.0 %). BIOSIM-EPO/REF price differences play no role at a global level (-10.8 % in Germany and -26.9 % in Japan).
  
  
  CONCLUSIONS
  EPO markets have proven to be highly country-specific. EPO market sizes, EPO retail/hospital distribution mixes and BIOSIM-EPO/REF price differences may not be determining factors of BIOSIM-EPO uptakes. Prescription and substitution incentives to use BIOSIM-EPO appear to be determining factors in Germany. The heterogeneity of national EPO markets makes it impossible to outline country profile types with significant BIOSIM-EPO penetrations.
authors.affiliation: Laboratory for the Economics and Management of Health Organizations, Dauphine University, Place du Maréchal de Lattre de Tassigny, 75775, Paris, CEDEX 16, France, francois.bocquet@parisdescartes.fr.
authors.forename: François
authors.initials: F
authors.lastname: Bocquet
authors.forename: Pascal
authors.initials: P
authors.lastname: Paubel
authors.forename: Isabelle
authors.initials: I
authors.lastname: Fusier
authors.forename: Anne-Laure
authors.initials: AL
authors.lastname: Cordonnier
authors.forename: Martine
authors.initials: M
authors.lastname: Sinègre
authors.forename: Claude
authors.initials: C
authors.lastname: Le Pen
mesh_terms: D059451:Biosimilar Pharmaceuticals / Q000191:economics*; D003362:Cost-Benefit Analysis / Q000706:statistics & numerical data; D016527:Drug Costs / Q000706:statistics & numerical data*; D004921:Erythropoietin / Q000737:chemistry / Q000145:classification* / Q000191:economics*; D005602:France; D005858:Germany; D006801:Humans; D007558:Italy; D007564:Japan; D008962:Models, Theoretical; D004366:Nonprescription Drugs / Q000191:economics*; D013030:Spain; D006113:United Kingdom
chemical_list: D059451:Biosimilar Pharmaceuticals; D004366:Nonprescription Drugs; D004921:Erythropoietin