Biosimilar Policies and Their Impact on Market Penetration of Adalimumab, Etanercept and Infliximab: A Policy Synthesis and Descriptive Analysis in 13 OECD Countries

Biosimilar medicines: overview | European Medicines Agency. https://www.ema.europa.eu/en/human-regulatory-overview/biosimilar-medicines-overview. Accessed 3 Jan 2024.

Biosimilars | FDA. https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars. Accessed 3 Jan 2024.

Biosimilars: what clinicians should know | Blood | American Society of Hematology. https://ashpublications.org/blood/article/120/26/5111/30935/Biosimilars-what-clinicians-should-know. Accessed 3 Jan 2024.

Haustein R, de Millas C, Höer A, Häussler B. Saving money in the European healthcare systems with biosimilars. Generics Biosimilars Initiat J. 2012;1(3–4):120–6. https://doi.org/10.5639/gabij.2012.0103-4.036.

Article  Google Scholar 

Troein P, Newton M, Stoddart K, Arias A. The impact of biosimilar competition in Europe 2022. https://www.iqvia.com/-/media/iqvia/pdfs/library/white-papers/the-impact-of-biosimilar-competition-in-europe-2022.pdf.

Prescribed drug spending in Canada, 2022 | CIHI. https://www.cihi.ca/en/prescribed-drug-spending-in-canada-2022. Accessed 8 Apr 2024.

Adalimumab expenditures in countries with and without available biosimilars. Center for Biosimilars. March 16, 2024. https://www.centerforbiosimilars.com/view/adalimumab-expenditures-in-countries-with-and-without-available-biosimilars. Accessed 30 Aug 2024.

Jarrion Q, Azzouz B, Robinson J, Jolly D, Vallet C, Trenque T. Penetration rate of anti-TNF biosimilars and savings at 5 years after their introduction in French hospitals. Therapies. 2022;77(4):467–75. https://doi.org/10.1016/j.therap.2021.10.012.

Article  Google Scholar 

Moorkens E, Jonker-Exler C, Huys I, Declerck P, Simoens S, Vulto AG. Overcoming barriers to the market access of biosimilars in the European Union: the case of biosimilar monoclonal antibodies. Front Pharmacol. 2016;7. https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2016.00193. Accessed 23 Feb 2024.

Arad N, Staton E, Lopez MH, Goriola S, McClellan M, Richman B. Realizing the benefits of biosimilars: overcoming rebate walls. Duke University; 2022. https://healthpolicy.duke.edu/sites/default/files/2022-03/Biosimilars%20-%20Overcoming%20Rebate%20Walls.pdf.

Arad N, Lopez MH, Ray R, et al. Realizing the benefits of biosimilars: what the U.S. Can learn from Europe. Duke University; 2021. https://healthpolicy.duke.edu/sites/default/files/2021-04/Realizing%20the%20Benefits%20of%20Biosimilars.pdf. Accessed 23 Feb 2024.

Edgar BS, Cheifetz AS, Helfgott SM, et al. Overcoming barriers to biosimilar adoption: real-world perspectives from a national payer and provider initiative. J Manag Care Spec Pharm. 2021;27(8):1129–35. https://doi.org/10.18553/jmcp.2021.27.8.1129.

Article  PubMed  Google Scholar 

Rémuzat C, Kapuśniak A, Caban A, et al. Supply-side and demand-side policies for biosimilars: an overview in 10 European member states. J Mar Access Health Policy. 2017;5(1):1307315. https://doi.org/10.1080/20016689.2017.1307315.

Article  Google Scholar 

e Patented Medicine Prices Review Board. Biologics in Canada Part 1: market trends 2018. May 2020. https://www.canada.ca/content/dam/pmprb-cepmb/documents/reports-and-studies/chartbooks/biologics-part1-market-trends.pdf. Accessed 8 Apr 2024.

Canada PMPRB. Canada’s evolving market for biosimilars and what it means for payers. May 16, 2022. https://www.canada.ca/en/patented-medicine-prices-review/services/npduis/analytical-studies/posters/evolving-market-biosimilars-payers.html. Accessed 8 Apr 2024.

List of OECD member countries—ratification of the convention on the OECD. https://www.oecd.org/about/document/ratification-oecd-convention.htm. Accessed 30 Apr 2024.

Government of Canada PW and GSC. Canada Gazette, Part 2, Volume 153, Number 17: regulations amending the patented medicines regulations (additional factors and information reporting requirements). August 21, 2019. https://canadagazette.gc.ca/rp-pr/p2/2019/2019-08-21/html/sor-dors298-eng.html. Accessed 30 Apr 2024.

Canada PMPRB. Potential sources for foreign prices: PMPRB11. July 5, 2022. https://www.canada.ca/en/patented-medicine-prices-review/services/are-you-patentee/potential-sources-foreign-prices.html. Accessed 30 Apr 2024.

Available IQVIA Data. https://www.iqvia.com/insights/the-iqvia-institute/available-iqvia-data. Accessed 22 Jan 2024.

MIDAS®. https://www.iqvia.com/solutions/commercialization/brand-strategy-and-management/market-measurement/midas. Accessed 22 Jan 2024.

World Health Organization Collaborating Centre for Drug Statistics Methodology. Defined daily dose (DDD). Guidelines for ATC classification and DDD assignment. https://www.who.int/tools/atc-ddd-toolkit/about-ddd. Accessed 22 Jan 2024.

Mulcahy AW, Schwam D, Rao P, Rennane S, Shetty K. Estimated savings from international reference pricing for prescription drugs. JAMA. 2021;326(17):1744–5. https://doi.org/10.1001/jama.2021.13338.

Article  PubMed  PubMed Central  Google Scholar 

Peng K, Blais JE, Pratt NL, et al. Impact of introducing infliximab biosimilars on total infliximab consumption and originator infliximab prices in eight regions: an interrupted time-series analysis. BioDrugs. 2023;37(3):409–20. https://doi.org/10.1007/s40259-023-00589-3.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Habashy C, Yemeke TT, Bolous NS, et al. Variations in global prices of chemotherapy for childhood cancer: a descriptive analysis. eClinicalMedicine. 2023. https://doi.org/10.1016/j.eclinm.2023.102005.

Article  PubMed  PubMed Central  Google Scholar 

Mardetko N, Nabergoj Makovec U, Locatelli I, Janez A, Kos M. Uptake of new antidiabetic medicines in 11 European countries. BMC Endocr Disord. 2021;21(1):127. https://doi.org/10.1186/s12902-021-00798-3.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Yan VKC, Li HL, Wei L, Knapp MRJ, Wong ICK, Chan EW. Evolving trends in consumption of direct oral anticoagulants in 65 countries/regions from 2008 to 2019. Drugs. 2023;83(4):315–40. https://doi.org/10.1007/s40265-023-01837-0.

Article  CAS  PubMed  Google Scholar 

Azuz S, Newton M, Bartels D, Poulsen BK. Uptake of biosimilar trastuzumab in Denmark compared with other European countries: a comparative study and discussion of factors influencing implementation and uptake of biosimilars. Eur J Clin Pharmacol. 2021;77(10):1495–501. https://doi.org/10.1007/s00228-021-03155-4.

Article  PubMed  PubMed Central  Google Scholar 

Le Pen C, Bauduceau B, Ansolabehere X, et al. Penetration rates of new pharmaceutical products in Europe: a comparative study of several classes recently launched in type-2 diabetes. Annales d’Endocrinologie. 2021;82(2):99–106. https://doi.org/10.1016/j.ando.2020.12.009.

Article  PubMed  Google Scholar 

OECD. Inflation (CPI) (indicator). Published online 2024. https://doi.org/10.1787/eee82e6e-en.

Piedade D, Verhelst H. Market review—biosimilar medicine markets 2020. Medicines for Europe; 2021. https://www.medicinesforeurope.com/biosimilar-medicines/whats-new/. Accessed 19 Dec 2022.

Vogler S, Schneider P, Zuba M, Busse R, Panteli D. Policies to encourage the use of biosimilars in European countries and their potential impact on pharmaceutical expenditure. Front Pharmacol. 2021;12. https://www.frontiersin.org/articles/10.3389/fphar.2021.625296. Accessed 15 Dec 2022.

Barbier L, Simoens S, Soontjens C, Claus B, Vulto AG, Huys I. Off-patent biologicals and biosimilars tendering in Europe—a proposal towards more sustainable practices. Pharmaceuticals. 2021;14(6):499. https://doi.org/10.3390/ph14060499.

Article  PubMed  PubMed Central  Google Scholar 

Simoens S, Cheung R. Tendering and biosimilars: what role for value-added services? J Mark Access Health Policy. 2020;8(1):1705120. https://doi.org/10.1080/20016689.2019.1705120.

Article  PubMed  Google Scholar 

McClean AR, Law MR, Harrison M, Bansback N, Gomes T, Tadrous M. Uptake of biosimilar drugs in Canada: analysis of provincial policies and usage data. CMAJ. 2022;194(15):E556–60. https://doi.org/10.1503/cmaj.211478.

Article  PubMed  PubMed Central  Google Scholar 

Tolonen HM, Falck J, Kurki P, et al. Is there any research evidence beyond surveys and opinion polls on automatic substitution of biological medicines? A systematic review. BioDrugs. 2021;35(5):547–61. https://doi.org/10.1007/s40259-021-00493-8.

Article  PubMed  PubMed Central  Google Scholar 

Moorkens E, Godman B, Huys I, 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. 2021;11. https://www.frontiersin.org/articles/10.3389/fphar.2020.591134. Accessed 22 Jan 2024.

"Prescribing “cheap”—INAMI. https://www.riziv.fgov.be/fr/professionnels/sante/medecins/soins/Pages/prescrire-bon-marche-20150101.aspx#Pourcentages_de_prescription_%C3%A0_atteindre_par_discipline. Accessed 6 Jan 2023.

Dranitsaris G, Jacobs I, Kirchhoff C, Popovian R, Shane LG. Drug tendering: drug supply and shortage implications for the uptake of biosimilars. CEOR. 2017;9:573–84. https://doi.org/10.2147/CEOR.S140063.

Article  Google Scholar 

Wangen AK, Pettersen MS. Perceptions of non-price criteria in pharmaceutical tenders : a case study on the Norwegian Market for generic antibiotics. Master thesis. Handelshøyskolen BI; 2022. https://biopen.bi.no/bi-xmlui/handle/11250/3035690. Accessed 23 Feb 2024.

Pharmaceutical strategy of the Norwegian Hospital Procurement Trust. Joint Nordic Specifications Regarding L01BA01 Methotrexate. https://www.sykehusinnkjop.no/49612e/siteassets/dokumenter/legemidler/joint-nordic-procurement/2020-2.620.b--draft-joint-nordic-tender-specifications.pdf. Accessed 10 May 2024.

PEREZ LOPEZ, Mulaku, Romanelli, Ribeiro. Assessment of tender adjudication criteria among European and leading emerging markets. https://www.ispor.org/docs/default-source/euro2021/tender-adjudication-criteriaispor-nov-2021e-poster-pdf.pdf?sfvrsn=bab96ad5_0. Accessed 23 Feb 2024.

Etanercept biosimilars delayed until 2029 in US. https://www.gabionline.net/biosimilars/news/etanercept-biosimilars-delayed-until-2029-in-us. Accessed 10 May 2024.

Zamecnik A. Humira biosimilars set the stage for long-awaited 2023 US launches. Pharmaceutical Technology. December 5, 2022. https://www.pharmaceutical-technology.com/features/humira-biosimilars-set-the-stage-for-long-awaited-2023-us-launches/. Accessed 10 May 2024.

Baker JF, Leonard CE, Re VL, Weisman MH, George MD, Kay J. Brief report: biosimilar uptake in the Academic and Veterans Health Administration settings: influence of institutional incentives. Arthritis Rheumatol. 2020;72(7):1067–71. https://doi.org/10.1002/art.41277.

Article  PubMed  PubMed Central  Google Scholar 

Thongpooswan S, Das A, Patil P, Latymer M, Llamado L, Wee J. Physicians’ and patients’ perception of biosimilars and factors affecting biosimilar prescribing in selected Asian countries: a survey study. Expert Opin Biol Ther. 2024;24(10):1171–82. https://doi.org/10.1080/14712598.2024.2400523.

Article  PubMed  Google Scholar 

Leonard E, Wascovich M, Oskouei S, Gurz P, Carpenter D. Factors affecting health care provider knowledge and acceptance of biosimilar medicines: a systematic review. JMCP. 2019;25(1):102–12. https://doi.org/10.18553/jmcp.2019.25.1.102.

Article  PubMed  Google Scholar 

Coghlan J, He H, Schwendeman AS. Overview of Humira® biosimilars: current European landscape and future implications. J Pharm Sci. 2021;110(4):1572–82. https://doi.org/10.1016/j.xphs.2021.02.003.

Article  CAS  PubMed  PubMed Central  Google Scholar 

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