Skip to main content
SpringerLink
Log in

Embracing Change: An International Survey Study on the Beliefs and Attitudes of Pediatric Rheumatologists Towards Biosimilars

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

Abstract

Background

Biosimilars have been adopted by clinicians more slowly than anticipated in the post-marketing phase.

Objectives

We aimed to reveal the perceptions and attitudes of pediatric rheumatologists towards biosimilars and the obstacles to biosimilar therapy.

Methods

A web-based survey designed to determine the knowledge, experience, and perceptions of pediatric rheumatologists about biosimilars was electronically mailed to the participants between April and August 2021. Responses were collected anonymously and subsequently analyzed.

Results

A total of 114 pediatric rheumatologists including fellows (32.4%), specialists (29.8%), and seniors (37.7%) responded to the questionnaire. According to the data, 75 (65.8%) physicians had already prescribed at least one biosimilar. The vast majority of participants were aware of the potential cost savings of biosimilars (84, 73.3%). Participants who felt insufficiently informed were 41.8%, 67.6%, and 83.7% among seniors, specialists, and fellows, respectively. In pediatric rheumatology, the scarcity of clinical trials and real-life data (64%) and inadequate information about tolerance to the biosimilars and related side effects in children (49.1%) were the most common barriers expressed by prescribers. Nearly half (45%) of the pediatric rheumatologists preferred to prescribe biosimilars in the treatment of biologic-naive cases. However, most (93%) were reluctant to switch a reference molecule to a biosimilar while the patient was doing well under the originator medicine.

Conclusions

This survey provided insights into the concerns about prescribing biosimilars among pediatric rheumatologists. In the field of pediatric rheumatology, further education about biosimilars and real-life experiences is required to better inform about treatment options in children.

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. Lahaye C, Tatar Z, Dubost JJ, Soubrier M. Overview of biologic treatments in the elderly. Jt Bone Spine. 2015;82(3):154–60.

    Article  Google Scholar 

  2. Strand V, Goncalves J, Isaacs JD. Immunogenicity of biologic agents in rheumatology. Nat Rev Rheumatol. 2021;17(2):81–97.

    Article  Google Scholar 

  3. Cimaz R, Maioli G, Calabrese G. Current and emerging biologics for the treatment of juvenile idiopathic arthritis. Expert Opin Biol Ther. 2020;20(7):725–40.

    Article  CAS  Google Scholar 

  4. Cabrera N, Lega JC, Kassai B, Wouters C, Kondi A, Cannizzaro E, et al. Safety of biological agents in paediatric rheumatic diseases: a real-life multicenter retrospective study using the JIRcohorte database. Jt Bone Spine. 2019;86(3):343–50.

    Article  Google Scholar 

  5. Kuemmerle-Deschner JB, Gautam R, George AT, Raza S, Lomax KG, Hur P. A systematic literature review of efficacy, effectiveness and safety of biologic therapies for treatment of familial Mediterranean fever. Rheumatology (Oxf). 2020;59(10):2711–24.

    Article  CAS  Google Scholar 

  6. Top selling biologics market, 2021–2030: focus on product landscape assessment, ongoing clinical trials, promotional content analysis, other life cycle management strategies, competition from biosimilars, annual treatment cost comparison, sales evolution and future opportunity. 2021. https://www.businesswire.com/news/home/20210803005814/en/Global-Top-Selling-Biologics-Market-Report-2021-2030---ResearchAndMarkets.com.

  7. Alfaleh MA, Alsaab HO, Mahmoud AB, Alkayyal AA, Jones ML, Mahler SM, et al. Phage display derived monoclonal antibodies: from bench to bedside. Front Immunol. 2020;11:1986.

    Article  CAS  Google Scholar 

  8. US Food and Drug Administration. Guidances (drugs): biosimilars. https://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances/ucm290967.htm. Accessed 28 Nov 2019.

  9. Moorkens E, Godman B, Huys I, Hoxha I, Malaj A, Keuerleber S, et al. The expiry of Humira® market exclusivity and the entry of adalimumab biosimilars in Europe: an overview of pricing and national policy measures. Front Pharmacol. 2020;11:591134.

    Article  CAS  Google Scholar 

  10. Leonard E. Factors affecting healthcare provider knowledge and acceptance of biosimilar medicines: a systematic review. J Manag Care Spec Pharm. 2019;25(1):102–12. https://doi.org/10.17615/cky7-df88.

    Article  PubMed  Google Scholar 

  11. O’Callaghan J, Bermingham M, Leonard M, Hallinan F, Morris JM, Moore U, et al. Assessing awareness and attitudes of healthcare professionals on the use of biosimilar medicines: a survey of physicians and pharmacists in Ireland. Regul Toxicol Pharmacol. 2017;88:252–61.

    Article  Google Scholar 

  12. Gibofsky A, McCabe D. US rheumatologists’ beliefs and knowledge about biosimilars: a survey. Rheumatology (Oxf). 2021;60(2):896–901.

    Article  CAS  Google Scholar 

  13. Cohen H, Beydoun D, Chien D, Lessor T, McCabe D, Muenzberg M, et al. Awareness, knowledge, and perceptions of biosimilars among specialty physicians. Adv Ther. 2017;33(12):2160–72.

    Article  Google Scholar 

  14. Beck M, Michel B, Rybarczyk-Vigouret MC, Levêque D, Sordet C, Sibilia J, et al. Rheumatologists’ perceptions of biosimilar medicines prescription: findings from a French web-based survey. BioDrugs. 2016;30(6):585–92.

    Article  Google Scholar 

  15. Reilly MS. Biosimilar substitution: European prescriber perspectives. Ann Oncol. 2019;30. https://www.annalsofoncology.org/article/S0923-7534(19)59837-4/pdf.

  16. Ismailov RM, Khasanova ZD. Biosimilar knowledge among oncology/hematology team members in Colorado, USA: an educational initiative and follow-up survey. BioDrugs. 2018;32(5):499–506.

    Article  CAS  Google Scholar 

  17. Leonard E, Wascovich M, Oskouei S, Gurz P, Carpenter D. Factors affecting health care provider knowledge and acceptance of biosimilar medicines: a systematic review. J Manag Care Spec Pharm. 2019;25(1):102–12.

    PubMed  Google Scholar 

  18. Maccora I, Lombardi N, Crescioli G, Bettiol A, Bonaiuti R, Pagnini I, et al. OBSIDIAn: real world evidence of Originator to BioSImilar Drug switch in juvenile idiopathic arthritis. Rheumatology (Oxf). 2021. https://doi.org/10.1093/rheumatology/keab572.

    Article  Google Scholar 

  19. Demirkan FG, Ulu K, Öztürk K, Karadağ ŞG, Özdel S, Sönmez HE, et al. Toward the integration of biosimilars into pediatric rheumatology: adalimumab ABP 501 experience of PeRA research group. Expert Opin Biol Ther. 2022;22(2):197–202.

    Article  CAS  Google Scholar 

  20. Sharma A, Minh Duc NT, Luu Lam Thang T, Nam NH, Ng SJ, Abbas KS, et al. A consensus-based checklist for reporting of survey studies (CROSS). J Gen Intern Med. 2021;36(10):3179–87.

    Article  Google Scholar 

  21. Pasina L, Casadei G, Nobili A. A survey among hospital specialists and pharmacists about biosimilars. Eur J Intern Med. 2016;35:e31–3.

    Article  Google Scholar 

  22. Cassar K, Zammit Dimech D, Grech L, Balzan D, Cutajar A, Cassar PJ. SAT0637-HPR biosimilars: the perception amongst Maltese clinicians. Ann Rheum Dis. 2016;75(Suppl. 2):1294.

  23. Cohen HP, Blauvelt A, Rifkin RM, Danese S, Gokhale SB, Woollett G. Switching reference medicines to biosimilars: a systematic literature review of clinical outcomes. Drugs. 2018;78(4):463–78.

    Article  CAS  Google Scholar 

  24. US Food and Drug Administration. Guidance for industry: immunogenicity assessment for therapeutic protein products. https://www.fda.gov/media/85017/download.

  25. Hoven Avd. Biosimilar medicines: practical EU experience and perspectives. Paper presented at the AAM Biosimilars Council Conference; 2017; Washington, DC.

  26. Barsell A, Rengifo-Pardo M, Ehrlich A. A survey assessment of US dermatologists’ perception of biosimilars. J Drugs Dermatol. 2017;16(6):612–5.

    PubMed  Google Scholar 

  27. Adé A, Bourdon O, Bussières JF. A survey of pharmacists’ knowledge and views of biosimilars in Quebec and France. Ann Pharm Fr. 2017;75(4):267–75.

    Article  Google Scholar 

  28. Waller J, Sullivan E, Piercy J, Black CM, Kachroo S. Assessing physician and patient acceptance of infliximab biosimilars in rheumatoid arthritis, ankylosing spondyloarthritis and psoriatic arthritis across Germany. Patient Prefer Adherence. 2017;11:519–30.

    Article  Google Scholar 

  29. Sullivan E, Piercy J, Waller J, Black CM, Kachroo S. Assessing gastroenterologist and patient acceptance of biosimilars in ulcerative colitis and Crohn’s disease across Germany. PLoS One. 2017;12(4):e0175826.

    Article  Google Scholar 

  30. Narayanan S, Nag S. Likelihood of use and perception towards biosimilars in rheumatoid arthritis: a global survey of rheumatologists. Clin Exp Rheumatol. 2016;34(1 Suppl. 95):S9-11.

    PubMed  Google Scholar 

  31. van Overbeeke E, De Beleyr B, de Hoon J, Westhovens R, Huys I. Perception of originator biologics and biosimilars: a survey among Belgian rheumatoid arthritis patients and rheumatologists. BioDrugs. 2017;31(5):447–59.

    Article  Google Scholar 

  32. Colloca L, Panaccione R, Murphy TK. The clinical implications of nocebo effects for biosimilar therapy. Front Pharmacol. 2019;10:1372.

    Article  CAS  Google Scholar 

  33. Pouillon L, Socha M, Demore B, Thilly N, Abitbol V, Danese S, et al. The nocebo effect: a clinical challenge in the era of biosimilars. Expert Rev Clin Immunol. 2018;14(9):739–49.

    Article  CAS  Google Scholar 

  34. Brower CK, editor. Too long and too boring: the effects of survey length and interest on careless responding. 2018. Wright State University, Ohio.

  35. Meade AW, Craig SB. Identifying careless responses in survey data. Psychol Methods. 2012;17(3):437–55.

    Article  Google Scholar 

Download references

Acknowledgements

We thank all the pediatric rheumatologists who participated in the study worldwide. We also thank Nicola Ruperto and PRINTO (Paediatric Rheumatology INternational Trials Organisation) and the PReS (European Society for Pediatric Rheumatology)-EMERGE (Emerging Rheumatologists and Researchers) group for disseminating the survey. All persons and members of the groups named in the Acknowledgments section have given us written permission to be named in the article.

Author information

Authors and Affiliations

  1. Department of Pediatric Rheumatology, İstanbul University, İstanbul School of Medicine, Istanbul, Turkey

    Fatma Gül Demirkan, Özlem Akgün & Nuray Aktay Ayaz

  2. Department of Pediatric Rheumatology, Kocaeli University, Kocaeli School of Medicine, Kocaeli, Turkey

    Hafize Emine Sönmez

  3. Department of Pediatrics, University Hospital Center, Zagreb, University of Zagreb School of Medicine, Zagreb, Croatia

    Lovro Lamot

  4. Department of Pediatric Rheumatology, University of Health Sciences, Ümraniye Research and Training Hospital, Istanbul, Turkey

    Betül Sözeri

Authors
  1. Fatma Gül Demirkan
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Hafize Emine Sönmez
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Lovro Lamot
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Özlem Akgün
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Betül Sözeri
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Nuray Aktay Ayaz
    View author publications

    You can also search for this author in PubMed Google Scholar

Consortia

For the PeRA-Research Group

Corresponding author

Correspondence to Nuray Aktay Ayaz.

Ethics declarations

Funding

No funding was received for the preparation of this article.

Conflict of interest

The authors declare that they have no conflicts of interest.

Ethics approval

This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of Istanbul University (no. 21.05.2021-204228).

Consent to participate

Each of the respondents filled out the questionnaire voluntarily.

Consent for publication

No personal or confidential data were collected.

Availability of data and material

The data underlying this article will be shared on reasonable request to the corresponding author.

Code availability

Not applicable.

Authors’ contributions

All authors whose names appear on the submission: (1) made substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data; or the creation of new software used in the work; (2) drafted the work or revised it critically for important intellectual content; (3) approved the version to be published; and (4) agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. All authors contributed to the study conception and design. Methodology: Nuray Aktay Ayaz. Formal analysis and investigation: Fatma Gül Demirkan. Writing, original draft preparation: Fatma Gül Demirkan, Hafize Emine Sönmez, Özlem Akgün. Writing, review, and editing: Lovro Lamot, Betül Sözeri.

Supplementary Information

Below is the link to the electronic supplementary material.

Supplementary file1 (PDF 639 kb)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Demirkan, F.G., Sönmez, H.E., Lamot, L. et al. Embracing Change: An International Survey Study on the Beliefs and Attitudes of Pediatric Rheumatologists Towards Biosimilars. BioDrugs 36, 421–430 (2022). https://doi.org/10.1007/s40259-022-00526-w

Download citation

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40259-022-00526-w

Search

Navigation