Skip to main content

Biosimilars for Psoriasis

  • Chapter
  • First Online:
Advances in Psoriasis
  • 645 Accesses

Abstract

Biologics have revolutionized the treatment of numerous conditions. While the therapeutic benefit of biologics has been dramatic, the development of these agents has been accompanied by significant increases in healthcare costs. Recently there has been growing interest in the development of biosimilar agents, which have the potential to decrease costs and improve access to this powerful class of medications. In this chapter, we discuss the legislative, regulatory, and scientific framework for the development and approval of biosimilars. We also review the current state of the biosimilars market as it relates to psoriasis, and examine current barriers to widespread utilization of biosimilar agents in clinical practice.

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

Access this chapter

eBook
USD 16.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 99.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 129.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  1. What Are “Biologics” Questions and Answers. U.S. Food & Drug Administration website. 2018. https://www.fda.gov/about-fda/about-center-biologics-evaluation-and-research-cber/what-are-biologics-questions-and-answers. Accessed June 26 2019.

  2. Yamauchi P (ed). Biosimilars in dermatology. In: Biologic and systemic agents in dermatology. New York, NY: Springer International Publishing; 2018.

    Google Scholar 

  3. Eisenstein M. Biosimilars: mimicking biological drugs. Nature Research. 2019. https://www.nature.com/articles/d41586-019-01400-6. Accessed July 1 2019.

  4. Carrascosa JM, Jacobs I, Petersel D, Strohal R. Biosimilar drugs for psoriasis: principles, present, and near future. Dermatol Ther (Heidelb). 2018;8(2):173–94.

    Article  Google Scholar 

  5. Sarpatwari A, Barenie R, Curfman G, Darrow JJ, Kesselheim AS. The US biosimilar market: stunted growth and possible reforms. Clin Pharmacol Ther. 2019;105(1):92–100.

    Article  Google Scholar 

  6. United States Securities and Exchange Commission. Novartis AG. 2015. https://www.sec.gov/Archives/edgar/data/1114448/000104746915000433/a2222787z20-f.htm#da72201_introduction_and_use_of_certain_terms. Accessed July 2, 2019.

  7. Derbyshire M. Patent expiry dates for biologicals: 2017 update. GaBI J. 2018;7(1):29–34.

    Article  Google Scholar 

  8. Yamauchi P, Crowley J, Kaur P, Spelman L, Warren R. Biosimilars: what the dermatologist should know. J Eur Acad Dermatol Venereol. 2018;32(7):1066–74.

    Article  CAS  Google Scholar 

  9. Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars. Ann Oncol. 2008;19:411–9.

    Article  CAS  Google Scholar 

  10. Schneider CK, Vleminckx C, Gravanis I, Ehmann F, Trouvin JH, Weise M, Thirstrup S. Setting the stage for biosimilar monoclonal antibodies. Nat Biotechnol. 2012;30:1179–85.

    Article  CAS  Google Scholar 

  11. U.S. Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product: guidance for industry. 2015. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf. Accessed June 23 2019.

  12. Chen BK, Yang YT, Bennett CL. Why biologics and biosimilars remain so expensive: despite two wins for biosimilars, the supreme court’s recent rulings do not solve fundamental barriers to competition. Drugs. 2018;78:1777–81.

    Article  Google Scholar 

  13. Schumock GT, Li EC, Wiest MD, et al. National trends in prescription drug expenditures and projections for 2017. Am J Health Syst Pharm. 2017;74(15):1158–73.

    Article  Google Scholar 

  14. Vanderpuye-Orgle J, Zhao Y, Lu J, et al. Evaluating the economic burden of psoriasis in the United States. J Am Acad Dermatol. 2015;72:961–7.

    Article  Google Scholar 

  15. Brezinski EA, Dhillon JS, Armstrong AW. Economic burden of psoriasis in the United States: a systematic review. JAMA Dermatol. 2015;151:651–8.

    Article  Google Scholar 

  16. Frank RG. Friction in the path to use of biosimilar drugs. N Engl J Med. 2018;378(9):791–3.

    Article  Google Scholar 

  17. Yamauchi P, Sachsman S, et al. Biosimilars in dermatology: analytical, regulatory, and clinical considerations: a treatise from the medical board of the national psoriasis foundation. J Psoriasis Psoriatic Arthritis. 2019:1–8.

    Google Scholar 

  18. Stewart J. How many biosimilars have been approved in the United States? Drugs.com website. 2019. https://www.drugs.com/medical-answers/many-biosimilars-approved-united-states-3463281/. Accessed June 27 2019.

  19. Rader R. Biosimilars/biobetters pipeline directory. Biotechnology Information Institute. 2018. Available at: http://www.biosimilarspipeline.com/. Accessed July 4, 2019.

  20. Global biosimilars market report 2018–2025—patent expiration of biologics to boost the biosimilars market. PR Newswire website. 2018. https://www.prnewswire.com/news-releases/global-biosimilars-market-report-2018-2025%2D%2D-patent-expiration-of-biologics-to-boost-the-biosimilars-market-300742485.html. Accessed July 1 2019.

  21. Kellen R, Goldberg G. Biosimilars in psoriasis: The future or not? Cutis. 2017 February;99(2):116–20.

    PubMed  Google Scholar 

  22. Chow SC, Wang J, Endrenyi L, Lachenbruch PA. Scientific considerations for assessing biosimilar products. Stat Med. 2013;32:370–81.

    Article  Google Scholar 

  23. Patel PK, King CR, Feldman SR. Biologics and biosimilars. J Dermatolog Treat. 2015;26(4):299–302.

    Article  Google Scholar 

  24. Smeeding J, Malone DC, Ramchandani M, Stolshek B, Green L, Schneider P. Biosimilars: considerations for payers. Pharmacy and Therapeutics. 2019;44(2):54–63.

    PubMed  PubMed Central  Google Scholar 

  25. Cohen AD, Wu JJ, Puig L, et al. Biosimilars for psoriasis: worldwide overview of regulatory guidelines, uptake and implications for dermatology clinical practice. Br J Dermatol. 2017;177:1495–502. https://doi.org/10.1111/bjd.15756.

    Article  CAS  PubMed  Google Scholar 

  26. U.S. Food and Drug Administration. Biologics price competition and innovation. 2009; H.R. 3590–697. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM216146.pdf. Accessed July 1 2019.

  27. Kuriakose A, Chirmule N, Nair P. Immunogenicity of biotherapeutics: causes and association with posttranslational modifications. J Immunol Res. 2016;2016(1298473)

    Google Scholar 

  28. Yoo DH, Hrycaj P, Miranda P, 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.

    Article  CAS  Google Scholar 

  29. Park W, Hrycaj P, Jeka S, 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.

    Article  CAS  Google Scholar 

  30. Committee for Medicinal Products for Human Use (CHMP). Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/01/WC500180219.pdf. Accessed 23 June 2019.

  31. Dearment A. A decade after biosimilars pathway’s creation, FDA issues final interchangeability rules. MedCityNews. 2019. https://medcitynews.com/2019/05/a-decade-after-creating-biosimilars-pathway-fda-issues-final-interchangeability-rules/. Accessed July 14 2019.

  32. Food and Drug Administration. Considerations in demonstrating interchangeability with a reference product—guidance for industry: draft guidance. 2019. www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM537135.pdf. Accessed July 14 2019.

  33. State laws and legislation related to biologic medications and substitution of biosimilars. 2018. http://www.ncsl.org/research/health/state-laws-and-legislation-related-to-biologic-medications-and-substitution-of-biosimilars.aspx. Accessed July 14 2019.

  34. National Psoriasis Foundation. Biosimilar substitution. 2015. https://www.psoriasis.org/about-psoriasis/treatments/statement-on-biosimilars. Accessed June 29 2019.

  35. Furlow B. The state of biosimilars in 2019. Modern medicine network. 2019. https://www.managedhealthcareexecutive.com/biosimilars/state-biosimilars-2019. Accessed July 15 2019.

  36. Fein A. Follow the dollar: the U.S. pharmacy distribution and reimbursement system. Drug Channels. 2016. https://www.drugchannels.net/2016/02/follow-dollar-us-pharmacy-distribution.html. Accessed July 7 2019.

  37. Jørgensen KK, Olsen IC, Goll GL, et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Lancet. 2017;389(10086):2304–16.

    Article  Google Scholar 

  38. Cohen H, Beydoun D, Chien D, et al. Awareness, knowledge, and perceptions of biosimilars among specialty physicians. Adv Ther. 2017;33:2160–72. https://doi.org/10.1007/s12325-016-0431-5.

    Article  PubMed  Google Scholar 

  39. Egeberg A, Ottosen MB, Gniadecki R, et al. Safety, efficacy, and drug survival of biologics and biosimilars for moderate-to-severe plaque psoriasis. Br J Dermatol. 2018;178(2):509–19.

    Article  CAS  Google Scholar 

  40. Singh SC, Bagnato KM. The economic implications of biosimilars. Am J Manag Care. 2015;21(16 suppl):S331–40.

    PubMed  Google Scholar 

  41. Cornes P. The economic pressures for biosimilar drug use in cancer medicine. Target Oncol. 2012;7:S57–67.

    Article  Google Scholar 

  42. Patel R, Clark M. Identifying the potential differences in management strategies between hospital and commercial payers regarding biosimilars: a national survey. J Manag Care Spec Pharm. 2015;21(suppl 4a):S85.

    Google Scholar 

  43. Rompas S, Goss T, Amanuel S, et al. Demonstrating value for biosimilars: a conceptual framework. Am Health Drug Benefits. 2015;8(3):129–39.

    PubMed  PubMed Central  Google Scholar 

  44. Mulcahy AW, Predmore Z, Mattke S. The cost savings potential of biosimilar drugs in the United States. The Rand Corporation. 2014. Accessed June 27 2019.

    Google Scholar 

  45. IQVIA Institute. Medicine use and spending in the U.S.: a review of 2017 and outlook to 2022. 2018. https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/medicine-use-and-spending-in-the-us-a-review-of-2017-and-outlook-to-2022.pdf?_=1562088649203. Accessed June 29 2019.

  46. Brill A, Ippolito B. Biologics are not natural monopolies. Health Affairs Blog. 2019. https://www.healthaffairs.org/do/10.1377/hblog20190701.349559/full/?utm_source=newsletter&utm_medium=email&utm_campaign=newsletter_axiosvitals&stream=top&. Accessed July 6 2019.

  47. Barsell A, Rengifo-Pardo M, Erlich A. A survey assessment of U.S. dermatologists’ perceptions of biosimilars. J Drugs Dermatol. 2017;16(6):612–5.

    PubMed  Google Scholar 

  48. Blauvelt A, Lacour JP, Fowler JF Jr, et al. Phase III randomized study of the proposed adalimumab biosimilar GP2017 in psoriasis: impact of multiple switches. Br J Dermatol. 2018;179(3):623–31.

    Article  CAS  Google Scholar 

  49. 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;16:336–43.

    PubMed  Google Scholar 

  50. Christl LA, Woodcock J, Kozlowski S. Biosimilars: The US regulatory framework. Annu Rev Med. 2017;68:243–54.

    Article  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2021 Springer Nature Switzerland AG

About this chapter

Check for updates. Verify currency and authenticity via CrossMark

Cite this chapter

Lonowski, S., Patel, N., Cyrus, N., Yamauchi, P.S. (2021). Biosimilars for Psoriasis. In: Weinberg, J.M., Lebwohl, M. (eds) Advances in Psoriasis. Springer, Cham. https://doi.org/10.1007/978-3-030-54859-9_22

Download citation

  • DOI: https://doi.org/10.1007/978-3-030-54859-9_22

  • Published:

  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-030-54858-2

  • Online ISBN: 978-3-030-54859-9

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics