Skip to main content
Log in

Knowledge of biosimilars and perceptions of the naming conventions for biosimilar products in clinical practice in the United States

  • Original Research Article
  • Published:
Drugs & Therapy Perspectives Aims and scope Submit manuscript

Abstract

Background

Biosimilar therapies and their naming conventions are both relatively new to the drug development market and in clinical practice. We studied the use of the four-letter naming convention in practice and the knowledge, perceptions, and preferences of US health care providers.

Methods

A survey was distributed among health care professionals with a history of utilizing biosimilars in clinical practice to measure key knowledge and the presence of discernable naming trends. Differences in responses across pre-hypothesized subgroups were tested for statistical significance.

Results

Of the 506 surveys emailed, 83 (16%) people responded. Overall, there was poor knowledge about the key concepts surrounding biosimilars. For example, only 52% of respondents correctly identified that biosimilars were not the same as the generic drug; however, frequent use correlated with superior knowledge across all groups. In reference to naming preferences, 67% of all respondents indicated that they commonly use the brand name to distinguish biosimilars in clinical practice and a majority of them (85%) indicated that the brand name was easier to remember than the nonproprietary name with the four-letter suffix. An unexpected number of neutral responses was documented. Notably, more than half of respondents (68%) indicated a neutral response when asked if the four-letter suffix promoted medical errors.

Conclusions

 There remains a knowledge gap with regard to biosimilars, and lack of consensus on how the naming convention is and should be utilized in clinical practice. The data also suggest that effective biosimilar education could aid in promoting familiarity with the naming convention among health care providers.

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

Access this article

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

Instant access to the full article PDF.

Fig. 1
Fig. 2
Fig 3

Similar content being viewed by others

References

  1. Nonproprietary Naming of Biological Products Guidance for Industry. US Department of Health and Human Services, US Food and Drug Administration Center for Biologics Evaluation and Research (CBER) & Center for Drug Evaluation and Research (CDER). 2017. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/nonproprietary-naming-biological-products-guidance-industry. Accessed 9 Jul 2020.

  2. H.R. 3590 Patient Protection and Affordable Care Act (Enrolled Bill [Final as Passed Both House and Senate]-ENR) Sec. 7002 approval pathway for biosimilar biological products. US Food and Drug Administration. https://www.fda.gov/media/78946/download. Accessed 9 Jul 2020.

  3. Biosimilar Drug Information. US Food and Drug Administration Center for Drug Evaluation and Research (CDER). 2020. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information. Accessed 9 Jul 2020.

  4. Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009 Guidance for Industry. US Department of Health and Human Services, US Food and Drug Administration Center for Biologics Evaluation and Research (CBER) & Center for Drug Evaluation and Research (CDER). 2021. https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. Accessed 9 Jul 2020.

  5. Nonproprietary Naming of Biological Products: Update Guidance for Industry. US Food and Drug Administration Center for Biologics Evaluation and Research (CBER) & Center for Drug Evaluation and Research (CDER). 2019. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/nonproprietary-naming-biological-products-update-guidance-industry. Accessed 19 Oct 2020.

  6. Kurki P, van Aerts L, Wolff-Holz E, et al. Interchangeability of biosimilars: a European perspective. BioDrugs. 2017;31(2):83–91.

    Article  CAS  Google Scholar 

  7. Leonard E, Wascovich M, Oskouei S, et al. 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 

  8. Barbier L, Simoens S, Vulto AG, et al. European stakeholder learnings regarding biosimilars: Part I-Improving biosimilar understanding and adoption. BioDrugs. 2020;34(6):783–96.

    Article  Google Scholar 

  9. 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 

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

    Article  Google Scholar 

  11. Manalo IF, Gilbert KE, Wu JJ. The current state of dermatologists’ familiarity and perspectives of biosimilars for the treatment of psoriasis: a global cross-sectional survey. J Drugs Dermatol. 2017;16(4):336–43.

    PubMed  Google Scholar 

  12. 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 

  13. van Overbeeke E, De Beleyr B, de Hoon J, et al. Perception of originator biologics and biosimilars: a survey among belgian rheumatoid arthritis patients and rheumatologists. BioDrugs. 2017;31(5):447–59.

    Article  Google Scholar 

  14. Teeple A, Ellis LA, Huff L, et al. Physician attitudes about non-medical switching to biosimilars: results from an online physician survey in the United States. Curr Med Res Opin. 2019;35(4):611–7.

    Article  CAS  Google Scholar 

  15. AMCP Partnership Forum. Biosimilars – ready, set. Launch J Manag Care Spec Pharm. 2016;22(4):434–40.

    Google Scholar 

  16. Greene L, Singh RM, Carden MJ, et al. Strategies for overcoming barriers to adopting biosimilars and achieving goals of the biologics price competition and innovation act: a survey of managed care and specialty pharmacy professionals. J Manag Care Spec Pharm. 2019;25(8):904–12.

    PubMed  Google Scholar 

Download references

Acknowledgements

Joshua Baker would like to acknowledge the support of a Veterans Affairs Clinical Science Research and Development Merit Award (I01 CX001703). The contents of this work do not represent the views of the Department of the Veterans Affairs or the United States Government.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Joshua F. Baker.

Ethics declarations

Funding

Dr. Leonard is partly supported by grants from the United States National Institutes of Health (R01AG060975) and the American Diabetes Association (1-18-ICTS-097). Dr. Baker is supported by a Veterans Affairs Clinical Science Research and Development VA Merit Award (I01 CX001703).

Conflicts of interest

Criswell Lavery, Marianna Olave, Vincent Lo Re, and Judy A. Shea declare they have no conflicts of interest. Charles Leonard reports grants from the FDA, during the conduct of this study; grants from the National Institutes of Health and the American Diabetes Association; personal fees from the American College of Clinical Pharmacy Research Institute and the University of Florida College of Pharmacy; other fees from Sanofi and Pfizer; and nonfinancial support from John Wiley & Sons, outside the submitted work. Jonathan Kay reports personal fees from AbbVie Inc., Alvotech Swiss AG, Boehringer Ingelheim Pharmaceuticals, Inc., Celltrion, Inc., Merck & Co., Inc., Mylan Pharma GmbH, Novartis Pharmaceuticals Corp., Samsung Bioepis Co., Ltd, Sandoz, Inc., and Roche Pharmaceuticals, as well as grants and personal fees from Pfizer, Inc. and UCB, Inc., outside the submitted work. Joshua Baker reports personal fees from Bristol-Myers Squibb and Gilead, outside the submitted work.

Availability of data and material 

All data and materials can be requested from the corresponding author upon request (bakerjo@uphs.upenn.edu).

Code availability

Not applicable.

Ethics approval

Not applicable.

Consent to participate

Not applicable.

Consent for publication

Not applicable.

Author contribution statement

All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by CL, MO, and JFB.

Supplementary Information

Below is the link to the electronic supplementary material.

Supplementary file1 (PDF 248 kb)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Olave, M., Lavery, C., Leonard, C.E. et al. Knowledge of biosimilars and perceptions of the naming conventions for biosimilar products in clinical practice in the United States. Drugs Ther Perspect 37, 338–346 (2021). https://doi.org/10.1007/s40267-021-00844-z

Download citation

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40267-021-00844-z

Navigation