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

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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).

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.

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Acknowledgments

No sources of funding were used to conduct this study. Data were kindly provided by IMS Health France. The authors are grateful to Stéphane Sclison and Yapi Anon for their assistance in collecting data from the IMS Health MIDAS database, and to Gary Stewart for editing the manuscript. The authors have no conflicts of interest that are directly relevant to the content of this article, and the opinions expressed are those of the authors. All authors have participated sufficiently to take responsibility for the entire content of the article. François Bocquet conceived and planned the work, analysed and interpreted the data, wrote the manuscript, and is responsible for the work as a whole. Pascal Paubel, Isabelle Fusier, Anne-Laure Cordonnier, Martine Sinègre and Claude Le Pen made significant contributions to the conception of the work, the analysis and the interpretation of the data, the revision of the manuscript, and approved the final submitted version.

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Authors and Affiliations

  1. Laboratory for the Economics and Management of Health Organizations, Dauphine University, Place du Maréchal de Lattre de Tassigny, 75775, Paris, CEDEX 16, France

    François Bocquet & Claude Le Pen

  2. Faculty of Pharmacy, Paris Descartes University, Sorbonne Paris Cité, Paris, France

    François Bocquet & Pascal Paubel

  3. Health Law Institute, Inserm, UMR S 1145, Paris Descartes University, Sorbonne Paris Cité, Paris, France

    François Bocquet & Pascal Paubel

  4. Therapeutic Evaluation Unit, General Agency of Equipment and Health Products (AGEPS), Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France

    François Bocquet, Isabelle Fusier, Anne-Laure Cordonnier & Martine Sinègre

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Bocquet, F., Paubel, P., Fusier, I. et al. Biosimilar Versus Patented Erythropoietins: Learning from 5 Years of European and Japanese Experience. Appl Health Econ Health Policy 13, 47–59 (2015). https://doi.org/10.1007/s40258-014-0125-6

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