Skip to main content
SpringerLink
Log in

Rheumatologists’ Perceptions of Biosimilar Medicines Prescription: Findings from a French Web-Based Survey

  • Original Research Article
  • Published:
BioDrugs Aims and scope Submit manuscript

    We’re sorry, something doesn't seem to be working properly.

    Please try refreshing the page. If that doesn't work, please contact support so we can address the problem.

Abstract

Background

Healthcare cost savings are closely linked to prescribers’ confidence in and acceptance of the prescription of biosimilar drugs.

Objectives

The aim of this study was to assess the knowledge, experience and opinions of hospital-based and office-based French rheumatologists with regard to biosimilar medicines and to identify the barriers to and possible options to promote their prescription.

Methods

A web-based, self-administered survey was conducted among French rheumatologists from June 8 to August 2, 2015.

Results

A total of 116 rheumatologists responded to the survey. Many reported having little knowledge and a lack of available information about biosimilar drugs, especially office-based rheumatologists. 98.3% of the respondents had at least one question about biosimilars, and seven in ten raised issues regarding substitution, iatrogenic effects or cost savings that might be achievable. Only eight rheumatologists had already prescribed a biosimilar drug. The most common barriers reported were indication extrapolation and a lack of data about tolerability. Nine out of ten physicians thought that starting a treatment with a biosimilar drug in biologic treatment-naïve patients was possible. The rheumatologists’ opinions were rather favorable towards the implementation of biosimilars, but a majority expressed a negative opinion about substitution by the pharmacist.

Conclusions

Our survey gave a better appreciation of the concerns associated with biosimilar prescriptions. Targeted communication initiatives, deeper experience and availability of new clinical data may help to address the outstanding questions and should overcome the misunderstandings surrounding biosimilar drugs among rheumatologists.

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
Fig. 2
Fig. 3
Fig. 4
Fig. 5

Similar content being viewed by others

References

  1. Braun J, Kudrin A. Progress in biosimilar monoclonal antibody development: the infliximab biosimilar CT-P13 in the treatment of rheumatic diseases. Immunotherapy. 2015;7:73–87. doi:10.2217/imt.14.109.

    Article  CAS  PubMed  Google Scholar 

  2. Weise M, Kurki P, Wolff-Holz E, Bielsky MC, Schneider CK. Biosimilars: the science of extrapolation. Blood. 2014;124:3191–6. doi:10.1182/blood-2014-06-583617.

    Article  CAS  PubMed  Google Scholar 

  3. Weise M, Bielsky M-C, De Smet K, Ehmann F, Ekman N, Giezen TJ, et al. Biosimilars: what clinicians should know. Blood. 2012;120:5111–7. doi:10.1182/blood-2012-04-425744.

    Article  CAS  PubMed  Google Scholar 

  4. Schneider CK. Biosimilars in rheumatology: the wind of change. Ann Rheum Dis. 2013;72:315–8.

    Article  CAS  PubMed  Google Scholar 

  5. Yoo DH. The rise of biosimilars: potential benefits and drawbacks in rheumatoid arthritis. Expert Rev Clin Immunol. 2014;10:981–3. doi:10.1586/1744666X.2014.932690.

    Article  CAS  PubMed  Google Scholar 

  6. Mysler E, Pineda C, Horiuchi T, Singh E, Mahgoub E, Coindreau J, et al. Clinical and regulatory perspectives on biosimilar therapies and intended copies of biologics in rheumatology. Rheumatol Int. 2016. doi:10.1007/s00296-016-3444-0.

    PubMed  PubMed Central  Google Scholar 

  7. European Medicines Agency (EMA). Guideline on similar biological medicinal products. CHMP/437/04. 23 October 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf. Accessed 22 Mar 2016.

  8. European Medicines Agency (EMA). Guideline on similar biological medicinal products containing monoclonal antibodies - non-clinical and clinical issues. EMA/CHMP/BMWP/403543/2010. 30 May 2012. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500128686.pdf. Accessed 29 Oct 2015.

  9. Bocquet F. Les Médicaments Biosimilaires: enjeux économiques et politiques. Paris: Éditions de santé; 2015.

    Google Scholar 

  10. Isaacs JD, Cutolo M, Keystone EC, Park W, Braun J. Biosimilars in immune-mediated inflammatory diseases: initial lessons from the first approved biosimilar anti-tumour necrosis factor monoclonal antibody. J Intern Med. 2016;279(1):41–59. doi:10.1111/joim.12432.

    Article  CAS  PubMed  Google Scholar 

  11. Gulácsi L, Brodszky V, Baji P, Kim H, Kim SY, Cho YY, et al. Biosimilars for the management of rheumatoid arthritis: economic considerations. Expert Rev Clin Immunol. 2015;11(Suppl 1):43–52. doi:10.1586/1744666X.2015.1090313.

    Article  Google Scholar 

  12. FirstWord Pharma. FirstWord Lists—the best selling drugs in 2014. http://www.firstwordpharma.com/node/1263906. Accessed 3 Mar 2016.

  13. Henry D, Taylor C. Pharmacoeconomics of cancer therapies: considerations with the introduction of biosimilars. Semin Oncol. 2014;41(Suppl 3):S13–20. doi:10.1053/j.seminoncol.2014.03.009.

    Article  PubMed  Google Scholar 

  14. Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM). Les médicaments biosimilaires—État des lieux, 2013. http://www.ansm.sante.fr/var/ansm_site/storage/original/application/6187b427efca64d2a15e496ff691158e.pdf. Accessed 22 Mar 2016.

  15. Kurki P, Ekman N. Biosimilar regulation in the EU. Expert Rev Clin Pharmacol. 2015;8:649–59. doi:10.1586/17512433.2015.1071188.

    Article  CAS  PubMed  Google Scholar 

  16. Tanabe K, Sugimoto N, Fujimoto Y. A web-based survey to investigate the extent of awareness and understanding for biosimilar among Japanese physicians and pharmacists. Value Health J Int Soc Pharmacoeconomics Outcomes Res. 2015;18:A658. doi:10.1016/j.jval.2015.09.2381.

    Article  CAS  Google Scholar 

  17. EuropaBio. ASBM survey of European prescribers understanding and knowledge of biosimilar medicines. http://www.europabio.org/asbm-survey-european-prescribers-understanding-and-knowledge-biosimilar-medicines. Accessed 3 Mar 2016.

  18. Danese S, Fiorino G, Michetti P. Viewpoint: knowledge and viewpoints on biosimilar monoclonal antibodies among members of the European Crohn’s and Colitis Organization. J Crohns Colitis. 2014;8:1548–50. doi:10.1016/j.crohns.2014.06.007.

    Article  PubMed  Google Scholar 

  19. Alliance for Safe Biologic Medicines (ASBM). Latin American physicians support distinguishable biosimilar naming, survey finds. http://safebiologics.org/resources/2015/06/latin-american-physicians-support-distinguishable-biosimilar-naming-survey-finds/. Accessed 22 Mar 2016.

  20. Institut National de la Statistique et des Etudes Economiques (Insee). Médecins suivant le statut et la spécialité en 2015. http://www.insee.fr/fr/themes/tableau.asp?reg_id=0&ref_id=NATTEF06102. Accessed 4 Mar 2016.

  21. Syndicat National des Médecins Rhumatologues, Société Française de Rhumatologie, Collège Français des Médecins Rhumatologues. Livre Blanc de la Rhumatologie Française 2015. http://sfr.larhumatologie.fr/rc/rhumatologie/htm/Article/2015/sfr-20151001-095142-363/src/htm_fullText/fr/Livre-Blanc-Rhumatologie-2015.pdf. Accessed 17 May 2016.

  22. European Medicines Agency (EMA). Assessment report Inflectra. EMA/CHMP/589422/2013. 27 June 2013. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002778/WC500151490.pdf. Accessed 17 Oct 2016.

  23. European Medicines Agency (EMA). Assessment report Remsima. EMA/CHMP/589317/2013. 27 June 2013. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002576/WC500151486.pdf. Accessed 17 Oct 2016.

  24. Park W, Hrycaj P, Jeka S, Kovalenko V, Lysenko G, Miranda P, et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis. 2013;72:1605–12. doi:10.1136/annrheumdis-2012-203091.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  25. Yoo DH, Hrycaj P, Miranda P, Ramiterre E, Piotrowski M, Shevchuk S, et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis. 2013;72:1613–20. doi:10.1136/annrheumdis-2012-203090.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  26. Annese V, Avendaño-Solá C, Breedveld F, Ekman N, Giezen TJ, Gomollón F, et al. Roundtable on biosimilars with European regulators and medical societies, Brussels, Belgium, 12 January 2016. Generics Biosimilars Initiat J (GaBI Journal). 2016;5(2):74–83. doi:10.5639/gabij.2016.0502.019.

    Article  Google Scholar 

  27. ClinicalTrials.gov. “Efficacy and Safety of Infliximab-biosimilar (Inflectra) Compared to Infliximab-innovator (Remicade) in Patients With Inflammatory Bowel Disease in Remission: the SIMILAR Trial”. https://clinicaltrials.gov/ct2/show/NCT02452151. Accessed 4 Mar 2016.

  28. Jung YS, Park DI, Kim YH, Lee JH, Seo PJ, Cheon JH, et al. Efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: a retrospective multicenter study. J Gastroenterol Hepatol. 2015;30:1705–12. doi:10.1111/jgh.12997.

    Article  CAS  PubMed  Google Scholar 

  29. Park SH, Kim Y-H, Lee JH, Kwon HJ, Lee S-H, Park DI, et al. Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea. Expert Rev Gastroenterol Hepatol. 2015;9(Suppl 1):35–44. doi:10.1586/17474124.2015.1091309.

    Article  PubMed  Google Scholar 

  30. British Society of Gastroenterology (BSG). Clinical trials updates—PANTS study. http://www.bsg.org.uk/research/clinical-trials-updates/index.html. Accessed 4 Mar 2016.

  31. Nikiphorou E, Kautiainen H, Hannonen P, Asikainen J, Kokko A, Rannio T, et al. Clinical effectiveness of CT-P13 (Infliximab biosimilar) used as a switch from Remicade (infliximab) in patients with established rheumatic disease. Report of clinical experience based on prospective observational data. Expert Opin Biol Ther. 2015;15:1677–83. doi:10.1517/14712598.2015.1103733.

    Article  CAS  PubMed  Google Scholar 

  32. Sieczkowska J, Jarzębicka D, Banaszkiewicz A, Plocek A, Gawronska A, Toporowska-Kowalska E, et al. Switching between infliximab originator and biosimilar in paediatric patients with inflammatory bowel disease. Preliminary observations. J Crohns Colitis. 2016;10:127–32. doi:10.1093/ecco-jcc/jjv233.

    Article  CAS  PubMed  Google Scholar 

  33. ClinicalTrials.gov. The NOR-SWITCH Study. https://clinicaltrials.gov/ct2/show/NCT02148640. Accessed 4 Mar 2016.

  34. Nederlands Trial Register. Trial info—the effect of switching treatment from innovator infliximab to infliximab biosimilar on efficacy, safety and immunogenicity in patients with rheumatoid arthritis, spondyloarthritis or psoriatic arthritis in daily clinical care—BIO-SWITCH study. http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5279. Accessed 4 Mar 2016.

  35. Faccin F, Tebbey P, Alexander E, Wang X, Cui L, Albuquerque T. The design of clinical trials to support the switching and alternation of biosimilars. Expert Opin Biol Ther. 2016;27:1–9. doi:10.1080/14712598.2017.1238454.

    Google Scholar 

  36. Reinisch W, Smolen J. Biosimilar safety factors in clinical practice. Semin Arthritis Rheum. 2015;44:S9–15. doi:10.1016/j.semarthrit.2015.04.005.

    Article  PubMed  Google Scholar 

  37. Haustein R, de Millas C, Höer A, Häussler H. Saving money in the European healthcare systems with biosimilars. Generics Biosimilars Initiat J. 2012;1:120–6.

    Article  Google Scholar 

  38. Brodszky V, Baji P, Balogh O, Péntek M. Budget impact analysis of biosimilar infliximab (CT-P13) for the treatment of rheumatoid arthritis in six Central and Eastern European countries. Eur J Health Econ. 2014;15:65–71. doi:10.1007/s10198-014-0595-3.

    Article  PubMed Central  Google Scholar 

  39. Jha A, Upton A, Dunlop WCN, Akehurst R. The budget impact of biosimilar infliximab (Remsima(®)) for the treatment of autoimmune diseases in five European countries. Adv Ther. 2015;32:742–56. doi:10.1007/s12325-015-0233-1.

    Article  PubMed  PubMed Central  Google Scholar 

  40. McCarthy G, Ebel Bitoun C, Guy H. Introduction of an infliximab biosimilar (CT-P13): a five-year budget impact analysis for the treatment of rheumatoid arthritis in Ireland. Value Health. 2013;16:A558. doi:10.1016/j.jval.2013.08.1465.

    Article  Google Scholar 

  41. Lucioni C, Mazzi S, Caporali R. Budget impact analysis of infliximab biosimilar: the Italian scenery. Glob Reg Health Technol Assess. 2015;2:78–88.

    Google Scholar 

  42. Kim J, Hong J, Kudrin A. 5 year budget impact analysis of biosimilar infliximab for the treatment of rheumatoid arthritis in UK, Italy, France and Germany. Arthritis Rheumatol. 2014;11:S512 (abstract 1166).

  43. Beck M, Michel B, Rybarczyk-Vigouret M-C, Sordet C, Sibilia J, Velten M. Biosimilar infliximab for the management of rheumatoid arthritis in France: what are the expected savings? Eur J Hosp Pharm. 2016:ejhpharm–2016–000904. doi:10.1136/ejhpharm-2016-000904.

Download references

Acknowledgements

The authors would like to thank all rheumatologists who participated in the pilot study for giving their impressions and advice—Marc Ardizzone, Hélène Bauer, Emmanuel Chatelus, Jacques-Eric Gottenberg, Paul Moreau, Nawal Rahal, Laëtitia Sparsa—and everyone who provided assistance in the survey’s dissemination: the “National Union of Rheumatologists” (Syndicat National des Médecins Rhumatologues) and the “Inflammatory Joint Disease Working Group of the French Society for Rheumatology” (Club “Rhumatismes et Inflammations”). The authors would like to thank Valérie Leray for proofreading and linguistic review of the manuscript. Last but not least, the authors would like to gratefully acknowledge all participants in the survey for completing the questionnaire.

Author contributions

MB conceived and designed the survey. BM, MCRV, DL, CS and MV were involved in validating the survey questionnaire. MB, CS and JS were involved in the survey’s dissemination. MB collected and analyzed the data. All authors checked the accuracy of the results. All authors were involved in drafting the article and revising it critically for important intellectual content. MB acts as guarantor for the content of the paper. All authors read and approved the final manuscript submitted for publication.

Author information

Author notes

    Authors and Affiliations

    1. OMEDIT Alsace, Agence Régionale de Santé Alsace Champagne-Ardenne Lorraine, 14, rue du Maréchal Juin, 67084, Strasbourg, France

      Morgane Beck, Bruno Michel & Marie-Christine Rybarczyk-Vigouret

    2. Service de Pharmacie-Stérilisation, C.H.R.U. Hôpitaux Universitaires de Strasbourg, Strasbourg, France

      Bruno Michel & Dominique Levêque

    3. Laboratoire HuManiS-EA 7308, Faculté de pharmacie, Université de Strasbourg, Strasbourg, France

      Bruno Michel

    4. Service de Rhumatologie, C.H.R.U. Hôpitaux Universitaires de Strasbourg, Strasbourg, France

      Christelle Sordet & Jean Sibilia

    5. Laboratoire d’épidémiologie et de santé publique-EA3430, Faculté de Médecine, Université de Strasbourg, Strasbourg, France

      Michel Velten

    Authors
    1. Morgane Beck
      View author publications

      You can also search for this author in PubMed Google Scholar

    2. Bruno Michel
      View author publications

      You can also search for this author in PubMed Google Scholar

    3. Marie-Christine Rybarczyk-Vigouret
      View author publications

      You can also search for this author in PubMed Google Scholar

    4. Dominique Levêque
      View author publications

      You can also search for this author in PubMed Google Scholar

    5. Christelle Sordet
      View author publications

      You can also search for this author in PubMed Google Scholar

    6. Jean Sibilia
      View author publications

      You can also search for this author in PubMed Google Scholar

    7. Michel Velten
      View author publications

      You can also search for this author in PubMed Google Scholar

    Consortia

    On behalf of the CRI (Club “Rhumatismes et Inflammations”)

    Corresponding author

    Correspondence to Morgane Beck.

    Ethics declarations

    Conflict of interest

    JS has received grants (<€10,000) from Roche, Pfizer, Abbvie, UCB and consulting fees or honorarium (<€1500) from Roche, Chugai, Bristol Myers Squibb, Abbott, UCB, GSK, LFB, Actelion, Pfizer, Merck Sharp, Novartis, Amgen, Hospira and Abbvie. MB, BM, MCRV, DL, CS and MV declare that they have no conflicts of interest.

    Funding

    This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.

    Additional information

    J. Sibilia and M. Velten contributed equally.

    Electronic supplementary material

    Below is the link to the electronic supplementary material.

    Supplementary material 1 (PDF 425 kb)

    Rights and permissions

    Reprints and permissions

    About this article

    Check for updates. Verify currency and authenticity via CrossMark

    Cite this article

    Beck, M., Michel, B., Rybarczyk-Vigouret, MC. et al. Rheumatologists’ Perceptions of Biosimilar Medicines Prescription: Findings from a French Web-Based Survey. BioDrugs 30, 585–592 (2016). https://doi.org/10.1007/s40259-016-0202-5

    Download citation

    • Published:

    • Issue Date:

    • DOI: https://doi.org/10.1007/s40259-016-0202-5

    Keywords

    Search

    Navigation