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.
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References
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.
Yamauchi P (ed). Biosimilars in dermatology. In: Biologic and systemic agents in dermatology. New York, NY: Springer International Publishing; 2018.
Eisenstein M. Biosimilars: mimicking biological drugs. Nature Research. 2019. https://www.nature.com/articles/d41586-019-01400-6. Accessed July 1 2019.
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.
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.
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.
Derbyshire M. Patent expiry dates for biologicals: 2017 update. GaBI J. 2018;7(1):29–34.
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.
Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars. Ann Oncol. 2008;19:411–9.
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.
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.
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.
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.
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.
Brezinski EA, Dhillon JS, Armstrong AW. Economic burden of psoriasis in the United States: a systematic review. JAMA Dermatol. 2015;151:651–8.
Frank RG. Friction in the path to use of biosimilar drugs. N Engl J Med. 2018;378(9):791–3.
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.
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.
Rader R. Biosimilars/biobetters pipeline directory. Biotechnology Information Institute. 2018. Available at: http://www.biosimilarspipeline.com/. Accessed July 4, 2019.
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.
Kellen R, Goldberg G. Biosimilars in psoriasis: The future or not? Cutis. 2017 February;99(2):116–20.
Chow SC, Wang J, Endrenyi L, Lachenbruch PA. Scientific considerations for assessing biosimilar products. Stat Med. 2013;32:370–81.
Patel PK, King CR, Feldman SR. Biologics and biosimilars. J Dermatolog Treat. 2015;26(4):299–302.
Smeeding J, Malone DC, Ramchandani M, Stolshek B, Green L, Schneider P. Biosimilars: considerations for payers. Pharmacy and Therapeutics. 2019;44(2):54–63.
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.
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.
Kuriakose A, Chirmule N, Nair P. Immunogenicity of biotherapeutics: causes and association with posttranslational modifications. J Immunol Res. 2016;2016(1298473)
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.
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.
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.
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.
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.
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.
National Psoriasis Foundation. Biosimilar substitution. 2015. https://www.psoriasis.org/about-psoriasis/treatments/statement-on-biosimilars. Accessed June 29 2019.
Furlow B. The state of biosimilars in 2019. Modern medicine network. 2019. https://www.managedhealthcareexecutive.com/biosimilars/state-biosimilars-2019. Accessed July 15 2019.
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.
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.
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.
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.
Singh SC, Bagnato KM. The economic implications of biosimilars. Am J Manag Care. 2015;21(16 suppl):S331–40.
Cornes P. The economic pressures for biosimilar drug use in cancer medicine. Target Oncol. 2012;7:S57–67.
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.
Rompas S, Goss T, Amanuel S, et al. Demonstrating value for biosimilars: a conceptual framework. Am Health Drug Benefits. 2015;8(3):129–39.
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.
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.
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.
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.
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.
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.
Christl LA, Woodcock J, Kozlowski S. Biosimilars: The US regulatory framework. Annu Rev Med. 2017;68:243–54.
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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
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