Skip to main content
SpringerLink
Log in

Biosimilar Granulocyte Colony-Stimulating Factor Uptakes in the EU-5 Markets: A Descriptive Analysis

  • Original Research Article
  • Published:
Applied Health Economics and Health Policy Aims and scope Submit manuscript

Abstract

Background

Biosimilars are copies of biological reference medicines. Unlike generics (copies of chemical molecules), biologics are complex, expensive and complicated to produce. The knowledge of the factors affecting the competition following patent expiry for biologics remains limited.

Objectives

The aims of this study were to analyse the EU-5 Granulocyte-Colony Stimulating Factor (G-CSF) markets and to determine the factors affecting the G-CSF biosimilar uptakes, particularly that of biosimilar prices relative to originators.

Methods

Data on medicine volumes, values, and ex-manufacturer prices for all G-CSF categories were provided by IMS Health. Volumes were calculated in defined daily doses (DDD) and prices in Euros per DDD. In the EU-5 countries, there is 5 years of experience with biosimilar G-CSFs (2007–2011).

Results

Two G-CSF market profiles exist: (1) countries with a high retail market distribution, which are the largest G-CSF markets with low global G-CSF biosimilar uptakes (5.4 % in France and 8.5 % in Germany in 2011); and (2) countries with a dominant hospital channel, which are the smallest markets with higher G-CSF biosimilar uptakes (12.4 % in Spain and 20.4 % in the UK). The more the decisions are decentralized, the more their uptakes are high. The price difference between G-CSF biosimilars and their reference plays a marginal role at a global level (price differences of +13.3 % in the UK and −20.4 % in France).

Conclusion

The competition with G-CSF biosimilars varies significantly between EU-5 countries, probably because of G-CSF distribution channel differences. Currently, this competition is not mainly based on prices, but on local political options to stimulate tendering between them and recently branded second- or third-generation products.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

References

  1. Generic medicines: essential contributors to the long-term health of society—sector sustainability challenges in Europe. IMS Health Report, 2010. http://www.egagenerics.com/index.php/publications/39-generic-medecines-essential-contributor . Accessed 27 Nov 2012.

  2. Haustein R, de Millas C, Hoër A, Häussler B. Saving money in the European healthcare systems with biosimilars. Generics Biosimilars Initiat J. 2012;1(3–4):120–6.

    Article  Google Scholar 

  3. Surveying tomorrow’s biopharma landscape—the NASDAQ Biotech Index up close evaluate Pharma, June 2012. http://info.evaluatepharma.com/rs/evaluatepharmaltd/images/EvaluatePharma_NBI_Up_Close_2012.pdf. Accessed 18 Oct 2013.

  4. Befrits G. The case for biosimilars: a payer’s perspective. Generics Biosimilars Initiat J. 2013;2(1):12.

    Article  Google Scholar 

  5. Schellekens H. How similar ‘biosimilars’ need to be? Nat Biotechnol. 2004;22(11):1357–9.

    Article  CAS  PubMed  Google Scholar 

  6. What you need to know about biosimilar medicinal products: process on corporate responsibility in the field of pharmaceuticals access to medicines in Europe. European Commission. Consensus Information Paper, 2013. http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/biosimilars_report_en.pdf. Accessed 17 Oct 2013.

  7. Schellekens H, Jiscoot W. Eprex-associated pure red cell aplasia and leachates. Nat Biotechnol. 2006;24(6):613–4.

    Article  CAS  PubMed  Google Scholar 

  8. Hermeling S, Schellekens H, Crommelin DJ, et al. Micelle-associated protein in epoietin formulations: a risk factor for immunogenicity? Pharm Res. 2003;20:1903–7.

    Article  CAS  PubMed  Google Scholar 

  9. Directive 2004/27/EC of the European Parliament and of the Council of 31st March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use. Off J Eur Union L 136:34–57. http://eur-lex.europa.eu/en/index.htm. Accessed 21 Nov 2012.

  10. Biosimilars: How much entry and price competition will result? Office of Health Economics Report based on the proceedings of an OHE Conference held on 2 June 2009 edited by Mattison N, Mestre-Ferrandiz J and Torse A, Dec. 2010. http://www.ohe.org/publications/article/biosimilars-how-much-entry-and-price-competition-will-result-13.cfm. Accessed 28 Nov 2012.

  11. Rovira J, Espín J, García L et al. The impact of biosimilars’ entry in the EU market. Andalusian School of Public Health Report for the European Commission (Directorate-General for Enterprise and Industry), Jan 2011. http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/biosimilars_market_012011_en.pdf. Accessed 25 Nov 2012.

  12. Godman B. Editorial: health authority perspective on biosimilars. Generics Biosimilars Initiat J. 2013;2(1):10–1.

    Article  Google Scholar 

  13. Bocquet F, Paubel P. Les aspects juridiques du développement des médicaments biosimilaires. Revue de Droit Sanitaire et Social. 2012;1:121–33.

    Google Scholar 

  14. The global use of medicines: outlook through 2016. IMS Health for Healthcare Informatics Report, July 2012. http://www.imshealth.com/deployedfiles/ims/Global/Content/Insights/IMS%20Institute%20for%20Healthcare%20Informatics/Global%20Use%20of%20Meds%202011/Medicines_Outlook_Through_2016_Report.pdf. Accessed 16 Nov 2012.

  15. Kowalchyk K, Crowley-Weber C. Biosimilars: impact of differences with Hatch-Waxman. Pharm Pat Anal. 2013;2(1):29–37.

    Article  CAS  PubMed  Google Scholar 

  16. IMS Institute for Healthcare Informatics. MIDAS, Dec 2010.

  17. Aggarwal S. What’s fueling the biotech engine 2009–2010. Nat Biotechnol. 2010;28(11):1165–71.

    Article  CAS  PubMed  Google Scholar 

  18. IMS Health. MIDAS database. La Défense: IMS Health; 2012.

    Google Scholar 

  19. Bocquet F, Paubel P, Fusier I et al. Biosimilar hematopoetic growth factors in the public hospitals of Paris: trade-offs between economic goals and evidence based medicine [abstract no. PCASE5 plus poster]. International Society for Pharmacoeconomics and Outcomes Research 15th Annual European Congress; 3–7 Nov 2012, Berlin.

  20. Power DA. Licensing and prescribing biosimilars in Australia. Generics Biosimilars Initiat J. 2013;2(3):152–4.

    Article  Google Scholar 

  21. European public assessment reports. European Medicines Agency (EMA), 2013. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d124. Accessed 22 Dec 2013.

  22. Chauhan D, Towse A, Mestre-Ferrandiz J. The market for biosimilars: evolution and policy options, OHE Briefing No. 45, Office of Health Economics, London. 2008. http://www.ohe.org/publications/article/the-market-for-biosimilars-evolution-and-policy-options-35.cfm. Accessed 13 Oct 2013.

  23. Grabowski HG, Ridley DB, Schulman KA. Entry and competition in generic biologicals. Manag Decis Econ. 2007;28(4–5):439–45.

    Article  Google Scholar 

  24. Shaping the biosimilars opportunity: a global perspective on the evolving biosimilars landscape. IMS Health Whitepaper, Dec 2011. http://www.imshealth.com/ims/Global/Content/Home%20Page%20Content/IMS%20News/Biosimilars_Whitepaper.pdf. Accessed 16 Oct 2012.

  25. Shaw BE, Confer DL, Hwang WY, et al. Concerns about the use of biosimilar granulocyte colony-stimulating factors for the mobilization of stem cells in normal donors: position of the World Marrow Donor Association. Haematologica. 2011;96(7):942–7.

    Article  PubMed Central  PubMed  Google Scholar 

  26. Kuderer N, Dale D, Crawford J, et al. Impact of primary prophylaxis with granulocyte colony-stimulating factor or febrile neutropenia and mortality in adult cancer patients receiving chemotherapy: a systematic review. J Clin Oncol. 2007;25:3158–67.

    Article  CAS  PubMed  Google Scholar 

  27. Lyman GH, Lyman CH, Agboola O. Risk models for predicting chemotherapy-induced neutropenia. Oncologist. 2005;10:427–37.

    Article  PubMed  Google Scholar 

  28. Lalami Y, Paesmans M, Aoun M, et al. A prospective randomized evaluation of G-CSF or G-CSF plus oral antibiotics in chemotherapy-treated patients at high risk of developing febrile neutropenia. Support Care Cancer. 2004;12:725–30.

    Article  CAS  PubMed  Google Scholar 

  29. WHO Collaborating Centre for Drug Statistics Methodology, 2009. http://www.whocc.no/ddd/definition_and_general_considera. Accessed 30 Nov 2012.

  30. Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. Off J Eur Union L 136:1–33. http://eur-lex.europa.eu/en/index.htm. Accessed 23 Nov 2012.

  31. WHO National Medicine Price Sources, 2010. http://www.who.int/entity/medicines/areas/access/sources_prices/National_Medicine_Price_Sources.pdf. Accessed 15 Nov 2012.

  32. IMS. Biosimilar accessible market: size and biosimilar penetration, prepared for EFPIA-EGA-EuropaBio, April 2012. http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/biosimilars_imsstudy_en.pdf. Accessed 7 Oct 2013.

  33. Eurostat, Demography—National Data—Population, 2010. http://appsso.eurostat.ec.europa.eu/nui/show.do?dataset=demo_pjan&lang=fr. Accessed 15 Nov 2012.

  34. Agence nationale de sécurité du médicament et des produits de santé, Répertoire des spécialités pharmaceutiques, 2013 [in French]. http://agence-prd.ansm.sante.fr/php/ecodex/index.php. Accessed 21 Dec 2013.

  35. L’assurance maladie, Base des médicaments et informations tarifaires, BdMIT, 2013 [in French]. http://www.codage.ext.cnamts.fr/codif/bdm_it/index.php?p_site=AMELI. Accessed 21 Dec 2013.

  36. Declerck P, Simoens S. A European perspective on the market accessibility of biosimilars. Biosimilars. 2012;2:33–40.

    Article  Google Scholar 

  37. Blackstone EA, Fuhr JP. The future of competition in the biologics market. Temple J Sci Technol Environ Law 2012; 31 L.1.

  38. Galizzi MM, Ghislandi S, Miraldo M. Effects of reference pricing in pharmaceutical markets: a review. Pharmacoeconomics. 2011;29(1):17–33.

    Article  PubMed  Google Scholar 

  39. Garuolienè K, Godman B, Gulbinovic J, Wettermark B, Haycox A. European countries with small populations can obtain low prices for drugs: Lithuania as a case history. Expert Rev Pharmacoecon Outcomes Res. 2011;11(3):343–9.

    Article  PubMed  Google Scholar 

  40. Puig-Junoy J. Impact of European pharmaceutical price regulation on generic price competition: a review. Pharmacoeconomics. 2010;28(8):649–63.

    Article  PubMed  Google Scholar 

  41. Danzon P, Ketcham J. Reference pricing of pharmaceuticals for Medicare: evidence from Germany, the Netherlands and New Zealand. Cambridge: National Bureau of Economic Research; 2004.

    Google Scholar 

  42. Puig-Junoy J. The impact of generic reference pricing interventions in the statin market. Health Policy. 2007;84(1):14–29.

    Article  PubMed  Google Scholar 

  43. National Institute for Health and Care Excellence, 2013. http://www.nice.org.uk/. Accessed 22 Dec 2013.

  44. National Health Service Commissioning Board, October 2012. http://www.england.nhs.uk/wp-content/uploads/2012/09/towards-establishment.pdf. Accessed 22 Dec 2013.

  45. Inspection Générale des Affaires Sociales-Inspection Générale des Finances (IGAS-IGF). Propositions pour la maîtrise de l’ONDAM, Jun 2012 [in French]. http://www.ladocumentationfrancaise.fr/rapports-publics/124000347-propositions-pour-la-maitrise-de-l-ondam-2013-2017. Accessed 22 Nov 2012.

  46. Project for the Financement of Social Security Act for 2013 (in French), Senate amendment n°28, 7 nov 2012. http://www.senat.fr/amendements/2012-2013/103/Amdt_28.html. Accessed 17 Nov 2012.

  47. Moreau A, Demolis P, Cavalié C. Les médicaments biosimilaires—Etat des lieux. ANSM Report, Sep 2013 [in French]. http://www.ansm.sante.fr/var/ansm_site/storage/original/application/6187b427efca64d2a15e496ff691158e.pdf. Accessed 17 Oct 2013.

  48. Chow S-C, Ju C. Assessing biosimilarity and interchangeability of biosimilar products under the Biologics Price Competition and Innovation Act. Generics Biosimilars Initiat J. 2013;2(1):20–5.

    Article  Google Scholar 

  49. Laslop A. Biosimilar monoclonal antibodies: challenges and opportunities in Europe. Generics Biosimilars Initiat J. 2013;2(3):110–1.

    Article  Google Scholar 

Download references

Acknowledgments

No sources of funding were used to conduct this study. Data were kindly provided by IMS Health France. The authors are grateful to S. Sclison and Y. Anon for their assistance in collecting data from the IMS Health MIDAS database.

François Bocquet, Pascal Paubel, Isabelle Fusier, Anne-Laure Cordonnier, Claude Le Pen and Martine Sinègre 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, Claude Le Pen and Martine Sinègre made significant contributions to the conception of the work, the analysis, the interpretation of the data, and revision of the manuscript, and approved the final submitted version.

Author information

Authors and Affiliations

  1. Dauphine University, Paris, 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

  5. Laboratoire d’Economie et de Gestion des Organisations de Santé, Université Paris-Dauphine, Place du Maréchal de Lattre de Tassigny, 75016, Paris, France

    François Bocquet

Authors
  1. François Bocquet
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Pascal Paubel
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Isabelle Fusier
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Anne-Laure Cordonnier
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Claude Le Pen
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Martine Sinègre
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to François Bocquet.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Bocquet, F., Paubel, P., Fusier, I. et al. Biosimilar Granulocyte Colony-Stimulating Factor Uptakes in the EU-5 Markets: A Descriptive Analysis. Appl Health Econ Health Policy 12, 315–326 (2014). https://doi.org/10.1007/s40258-014-0087-8

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40258-014-0087-8

Keywords

Search

Navigation