Clinical Rheumatology

, Volume 34, Issue 8, pp 1427–1433 | Cite as

Attitudes towards subsequent entry biologics/biosimilars: A survey of Canadian rheumatologists

  • David Grabowski
  • Bradley Henderson
  • Dennis Lam
  • Edward C. Keystone
  • Carter Thorne
  • Shahin Jamal
  • Janet Pope
  • Boulos Haraoui
  • Daming Lin
  • Leigh ReversEmail author
Original Article


Globally, patents on several well established biologic agents used to treat rheumatic diseases have already or will expire over the next few years, allowing for the availability of subsequent entry biologics (SEBs or biosimilars). The objective of this study was to identify gaps in knowledge and attitudes towards SEBs among Canadian rheumatologists. Eighty-one rheumatologists completed the survey and were included in the analysis (22 % of the 369 who were contacted). We found that one third of physicians (31 %) were familiar with SEBs and that physicians with greater than 20 years of practice were significantly more likely to be familiar or very familiar with SEBs compared to respondents with less than 10 years or 10–20 years of experience (OR 11.1, 95 % CI: 2.1–55.5, p = 0.004 and OR 4.5, 95 % CI: 1.2–16.2, p = 0.023, respectively). A third (32 %) of physicians agreed or strongly agreed that they would be comfortable with indication extrapolation. Most respondents (88 %) would feel concerned or very concerned if a pharmacist had the ability to substitute a biologic drug for an SEB without the physician’s approval. This survey was the first study that evaluated the position of rheumatologists on key areas surrounding SEBs from a nationwide Canadian perspective. Current physician attitudes and perceptions of SEBs can inform future educational initiatives and highlight important issues for payers, policy makers, and other stakeholders.


Biosimilars Rheumatology Subsequent entry biologics Survey 



We would like to thank all the physicians who took time to complete our survey and share their opinions, as well as the Canadian Rheumatology Association (CRA) for making this study possible. We would also like to thank Christine Charnock and Virginia Hopkins of the CRA for their continuous support in coordinating the survey during the launch, maintenance, and closure phases. This study was funded by MBiotech Innovation Bursaries awarded to Messrs. Grabowski, Henderson and Lam. The lottery incentive for the survey was provided by the CRA.

Conflict of interest

Drs. Keystone, Thorne, Jamal, Pope, Haraoui, and Revers have received honoraria from the pharmaceutical industry in the past, but declare no conflict of interest in relation to the present study. Messrs. Grabowski, Henderson and Lam have been undertaking this research as part of their graduate training at the Institute of Management of Innovation, University of Toronto Mississauga. Messrs. Grabowski and Lam are currently employees of Boehringer Ingelheim and Janssen, respectively. Mr. Henderson was an employee of Amgen and Janssen during the study.

Supplementary material

10067_2014_2835_MOESM1_ESM.pdf (68 kb)
ESM 1 (PDF 67 kb)


  1. 1.
    Upchurch KS, Kay J (2012) Evolution of treatment of rheumatoid arthritis. Rheumatology 51:vi28–vi36Google Scholar
  2. 2.
    Revers L, Furczon E (2010) An introduction to biologics and biosimilars. Part II: Subsequent Entry Biologics: Biosame or Biodifferent? Can Pharm J 143:184-191Google Scholar
  3. 3.
    Scheinberg MA, Kay J (2012) The advent of biosimilar therapies in rheumatology — “O brave new world.” Nat Rev Rheumatol 8:430–436Google Scholar
  4. 4.
    Schiestl M, Stangler T, Torella C, Čepeljnik T, Toll H, Grau R (2011) Acceptable changes in quality attributes of glycosylated biopharmaceuticals. Nature Biotechnol 29:310–312Google Scholar
  5. 5.
    Kay J, Feagan BG, Guirguis MS, Keystone EC, Klein AV, Lubiniecki AS, Mould DR, Nyarko KA, Ridgway AAG, Trudeau ME, Wang J (2012) Health Canada/BIOTECanada Summit on Regulatory and Clinical Topics Related to Subsequent Entry Biologics (Biosimilars), Ottawa, Canada, 14 May 2012. Biologicals 40:517–527Google Scholar
  6. 6.
    Farfan-Portet MI, Gerkens S, Lepage-Nefkens I, Vinck I, Hulstaert F (2014) Are biosimilars the next tool to guarantee cost-containment for pharmaceutical expenditures? Eur J Health Econ 15:223Google Scholar
  7. 7.
    Dörner TSV, Castañeda-Hernández G, Ferraccioli G, Isaacs JD, Kvien TK, Martin-Mola E, Mittendorf T, Smolen JS, Burmester GR (2013) The role of biosimilars in the treatment of rheumatic diseases. Ann Rheum Dis 72:322–328Google Scholar
  8. 8.
    Papp K, Bourcier M, Ho V, Burke V, Haraoui B (2013) Preparing for subsequent entry biologics in dermatology and rheumatology in Canada. J Cutan Med Surg 17:340–346Google Scholar
  9. 9.
    Ndegwa S, Quansah K. Subsequent entry biologics – Emerging trends in regulatory and health technology assessment frameworks [Environmental Scan, Issue 43, ES0284]. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2014Google Scholar
  10. 10.
    Haustein R, de Millas C, Höer A, Häussler H (2012) Saving money in the European healthcare systems with biosimilars. Generics Biosimilars Initiat J, 1(3-4):120–126Google Scholar
  11. 11.
    Ontario Rheumatology Association (2012) Position paper on subsequent entry biologics/biosimilarsGoogle Scholar
  12. 12.
    Russell AS, Vandana A, Barnabe C, Jamal S, Offer RC, Olszynski WP, Shojania K, Haraoui B (2012) Subsequent entry biologics/biosimilars: A viewpoint from Canada. Clin Rheumatol 31:1289–1292Google Scholar
  13. 13.
    Canadian Dermatology Association (2013) Canadian Dermatology Association Position Statement: BiosimilarsGoogle Scholar
  14. 14.
    Devlin SM, Bessler B, Bernstein CN, Fedorak RN, Bitton A, Singh H, Feagan BG (2013) Overview of subsequent entry biologics for management of inflammatory bowel disease and Canadian Association of Gastroenterology statement on subsequent entry biologics. Can J Gastroenterol 27:567–571Google Scholar
  15. 15.
    Park W, Hrycaj P, Jeka S, Kovalenko V, Lysenko G, Miranda P, Mikazane H, Gutierrez-Ureña S, Lim M, Lee YA, Kim H, Yoo DH, Braun J (2013) 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 72:1605–1612Google Scholar
  16. 16.
    Yoo DH, Hrycaj P, Miranda P, Ramiterre E, Piotrowski M, Shevchuk S, Kovalenko V, Prodanovic N, Abello-Banfi M, Gutierrez-Ureña S, Morales-Olazabal L, Tee M, Jimenez R, Zamani O, Lee SJ, Kim H, Park W, Müller-Ladner U (2013) 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 72:1613–1620Google Scholar
  17. 17.
    Health Canada Food and Drugs Branch (2010) Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs). Health Canada, Ottawa, CanadaGoogle Scholar
  18. 18.
    Yoo DH, Prodanovic N, Jaworski J, Miranda P, Ramiterre EB, Baranauskaite A, Wiland P, Abud-Mendoza C, Oparanoc B, Son YK, Park W, Muller-Ladner U. Efficacy and safety of CT-P13 (infliximab biosimilar) over two years in patients with rheumatoid arthritis: Comparison between continued CT-P13 and switching from infliximab to CT-P13. Abstract presented at: Annual Meeting of the American College of Rheumatology; 26-29 October 2013; San Diego, CAGoogle Scholar
  19. 19.
    Health Canada Food and Drugs Branch (2010) Questions & Answers to Accompany the Final Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs). Health Canada, Ottawa, CanadaGoogle Scholar
  20. 20.
    Colbert RA, Cronstein BN (2011). Biosimilars: the debate continues. Arthritis Rheum 63:2848–2850Google Scholar
  21. 21.
    Haraoui B, Bensen W, Bessette L, Le Clercq S, Thorne C, Wade J (2012) Treating rheumatoid arthritis to target: A Canadian physician survey. J Rheumatol 39:949–953Google Scholar
  22. 22.
    National Physician Survey (2013) 2013 National Physician Survey (NPS): Demographics for internal medicine specialists. National Physician Survey, MississaugaGoogle Scholar
  23. 23.
    National Physician Survey (2010) 2010 National Physician Survey (NPS): Demographics for internal medicine specialists. National Physician Survey, MississaugaGoogle Scholar
  24. 24.
    Nederhof AJ (1985) Methods of coping with social desirability bias: A review. Eur J Soc Psychol 15:263–280Google Scholar

Copyright information

© International League of Associations for Rheumatology (ILAR) 2015

Authors and Affiliations

  • David Grabowski
    • 1
  • Bradley Henderson
    • 1
  • Dennis Lam
    • 1
  • Edward C. Keystone
    • 2
  • Carter Thorne
    • 3
  • Shahin Jamal
    • 4
  • Janet Pope
    • 5
  • Boulos Haraoui
    • 6
  • Daming Lin
    • 2
  • Leigh Revers
    • 1
    Email author
  1. 1.Institute of Management & InnovationUniversity of Toronto MississaugaMississaugaCanada
  2. 2.Mount Sinai Hospital, TorontoTorontoCanada
  3. 3.Southlake Regional Health CentreNewmarketCanada
  4. 4.University of British ColumbiaVancouverCanada
  5. 5.University of Western OntarioLondonCanada
  6. 6.CHUM, Hôpital Notre-DameUniversité de MontréalMontréalCanada

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