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Knowledge and use of biosimilars in oncology: a survey by the European Society for Medical Oncology
  1. Rosa Giuliani1,
  2. Josep Tabernero2,
  3. Fatima Cardoso3,
  4. Keith Hanson McGregor4,
  5. Malvika Vyas5,
  6. Elisabeth G E de Vries6
  1. 1Medical Oncology, San Camillo-Forlanini Hospital, Rome, Italy
  2. 2Vall d’Hebron University Hospital and Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona, Spain
  3. 3Breast Unit, Champalimaud Clinical Center/Champalimaud Foundation, Lisbon, Portugal
  4. 4Chief Executive Officer, European Society for Medical Oncology (ESMO), Lugano, Switzerland
  5. 5Head of Public Policy, European Society for Medical Oncology, Lugano, Switzerland
  6. 6Department of Medical Oncology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands
  1. Correspondence to Professor Elisabeth G E de Vries; e.g.e.de.vries{at}umcg.nl

Abstract

Background Biosimilars can potentially improve the sustainability of cancer care; however, uptake is sometimes limited by safety concerns and a lack of understanding of the concept of extrapolation. The European Society for Medical Oncology (ESMO) conducted a survey to assess the current level of knowledge, understanding and comfort of use of biosimilars among prescribers specialised in oncology.

Methods A 19-question survey was developed using the SurveyMonkey online platform (https://www.surveymonkey.com/). Data collection occurred between September and October 2017 and included paper and online responses.

Results Overall, 393 responses were received from prescribers. Overall, 49.0% of prescribers use biosimilars in clinical practice and most (79.2%) rate their general knowledge of biosimilars as average to very high. Potential increased risk of immunogenicity remains a significant concern of switching. Gaps in knowledge identified by the survey include biosimilar development, clinical trial design and endpoint selection, and requirements for extrapolation, which should form the focus of future educational initiatives. A substantial demand remains for further educational activities with equal preference for online and face-to-face initiatives. A higher rate of biosimilar use (56.3% vs 46.5%), knowledge of biosimilar development and trial design, and comfort with extrapolation, but a lower knowledge of European Medicines Agency definitions, was found among prescribers from Asia-Pacific versus those from Europe.

Conclusion Encouraging levels of prescriber use and general knowledge of biosimilars were found, but a substantial need for further education remains. Efforts should be made worldwide to align terms, definitions and guidelines for the development and approval of biosimilars.

  • biosimilars
  • oncology
  • prescribers
  • extrapolation
  • switching

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Footnotes

  • Correction notice This article has been corrected since it first published online. The open access licence type has been amended.

  • Contributors RG was responsible for the study design, the writing, and final approval of the manuscript. FC was responsible for the study design, the writing, and final approval of the manuscript. KHM was responsible for the study design, the writing, and final approval of the manuscript. MV was responsible for the study design, the writing, and final approval of the manuscript. EGEdV was responsible for the study design, the writing, and final approval of the manuscript. All authors agree to be accountable for all aspects of the work. Monica Gheorghe was responsible for data collection and statistical analysis. Editorial support was provided by Terri Penfold of Spirit Medical Communications Ltd.

  • Competing interests JT reports consultancy roles for Array Biopharma, AstraZeneca, Bayer, BeiGene, Boehringer Ingelheim, Chugai, Genentech Inc., Genmab A/S, Halozyme, Imugene Limited, Inflection Biosciences Limited, Ipsen, Kura Oncology, Lilly, MSD, Menarini, Merck Serono, Merrimack, Merus, Molecular Partners, Novartis, Peptomyc, Pfizer, Pharmacyclics, ProteoDesign SL, Rafael Pharmaceuticals, F. Hoffmann-La Roche Ltd, Sanofi, SeaGen, Seattle Genetics, Servier, Symphogen, Taiho, VCN Biosciences, Biocartis, Foundation Medicine, HalioDX SAS and Roche Diagnostics; and institutional grants from Agendia BV, Amgen SA, Debiopharm International SA, Janssen-Cilag SA, Mologen AG, Novartis Farmacéutica SA, Pharma Mar, Roche Farma SA, Laboratorios Servier SL and Symphogen A/S. FC reports consultancy roles for Amgen, Astellas/Medivation, AstraZeneca, Celgene, Daiichi-Sankyo, Eisai, GE Oncology, Genentech, GlaxoSmithKline, Macrogenics, Merck-Sharp, Merus BV, Mylan, Mundipharma, Novartis, Pfizer, Pierre-Fabre, Roche, Sanofi, Seattle Genetics, Samsung Bioepis and Teva. EGEdV reports consultancy/advisory roles for Daiichi Sankyo, Merck, NSABP, Pfizer and Sanofi; and institutional grants from Amgen, AstraZeneca, Bayer, Chugai Pharma, CytomX Therapeutics, G1 Therapeutics, Genentech, Nordic Nanovector, Radius Health, Regeneron, Roche, Servier and Synthon.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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