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Biosimilar Versus Patented Erythropoietins: Learning from 5 Years of European and Japanese Experience

Bocquet, François; Paubel, Pascal; Fusier, Isabelle; Cordonnier, Anne-Laure; Sinègre, Martine; Le Pen, Claude (2015), Biosimilar Versus Patented Erythropoietins: Learning from 5 Years of European and Japanese Experience, Applied Health Economics and Health Policy, 13, 1, p. 47-59. 10.1007/s40258-014-0125-6

Type
Article accepté pour publication ou publié
Date
2015
Journal name
Applied Health Economics and Health Policy
Volume
13
Number
1
Publisher
Springer
Pages
47-59
Publication identifier
10.1007/s40258-014-0125-6
Metadata
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Author(s)
Bocquet, François
Institut Droit et Santé [IDS - U1145]
Paubel, Pascal
Institut Droit et Santé [IDS - U1145]
Fusier, Isabelle

Cordonnier, Anne-Laure

Sinègre, Martine

Le Pen, Claude
Abstract (EN)
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). Objectives 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.
Subjects / Keywords
Drug industry; Medical economics; Erythropoietins
JEL
I12 - Health Behavior
L65 - Chemicals; Rubber; Drugs; Biotechnology
I11 - Analysis of Health Care Markets

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