United Nations Development Program. What are the sustainable development goals?. https://www.undp.org/sustainable-development-goals#good-health. Accessed 17 Mar 2023

Organization for Economic Co-operation and Development. Pharmaceutical spending (indicator). https://data.oecd.org/healthres/pharmaceutical-spending.htm. Accessed 23 Jan 2023.

World Health Organization. WHO guideline on country pharmaceutical pricing policies. 2nd ed. Geneva: World Health Organization; 2020.

Google Scholar 

World Health Organization. Pricing of cancer medicines and its impacts. Geneva: World Health Organization; 2018.

Google Scholar 

Laires PA, Exposto F, Mesquita R, Martins AP, Cunha-Miranda L, Fonseca JE. Patients’ access to biologics in rheumatoid arthritis: a comparison between Portugal and other European countries. Eur J Health Econ. 2013;14:875–85.

Article  CAS  PubMed  Google Scholar 

Peeters M, Planchard D, Pegram M, Gonçalves J, Bocquet F, Jang H. Biosimilars in an era of rising oncology treatment options. Future Oncol. 2021;17:3881–92.

Article  CAS  PubMed  Google Scholar 

IQVIA Institute for Human Data Science. Spotlight on Biosimilars—Optimising the sustainability of healthcare systems. 2021.

Burisch J, Vardi H, Schwartz D, Friger M, Kiudelis G, Kupčinskas J, et al. Health-care costs of inflammatory bowel disease in a pan-European, community-based, inception cohort during 5 years of follow-up: a population-based study. Lancet Gastroenterol Hepatol. 2020;5:454–64.

Article  PubMed  Google Scholar 

World Health Organization. Guidelines on evaluation of biosimilars. WHO Expert Comm Biol Stand Seventy-Fifth Rep. Geneva: World Health Organization. 2022. https://apps.who.int/iris/handle/10665/362194.

EMA. Biosimilar medicines: Overview. Eur. Med. Agency. 2018. https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines-overview. Accessed 17 Nov 2022.

Brodszky V, Baji P, Balogh O, Péntek M. Budget impact analysis of biosimilar infliximab (CT-P13) for the treatment of rheumatoid arthritis in six Central and Eastern European countries. Eur J Health Econ. 2014;15:65–71.

Article  PubMed Central  Google Scholar 

Gleeson D, Townsend B, Lopert R, Lexchin J, Moir H. Financial costs associated with monopolies on biologic medicines in Australia. Aust Health Rev. 2019;43:36.

Article  PubMed  Google Scholar 

Agirrezabal I, Sánchez-Iriso E, Mandar K, Cabasés JM. Real-world budget impact of the adoption of insulin glargine biosimilars in primary care in England (2015–2018). Diabetes Care. 2020;43:1767–73.

Article  CAS  PubMed  Google Scholar 

Barszczewska O, Piechota A. The impact of introducing successive biosimilars on changes in prices of adalimumab, infliximab, and trastuzumab—polish experiences. Int J Environ Res Public Health. 2021;18:6952.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Kim Y, Kwon H-Y, Godman B, Moorkens E, Simoens S, Bae S. Uptake of biosimilar infliximab in the UK, France, Japan, and Korea: budget savings or market expansion across countries? Front Pharmacol. 2020;11:970.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Barbier L, Mbuaki A, Simoens S, Declerck P, Vulto AG, Huys I. Regulatory information and guidance on biosimilars and their use across Europe: a call for strengthened one voice messaging. Front Med. 2022;9:820755.

Article  Google Scholar 

IQVIA Institute for Human Data Science. The impact of biosimilar competition in Europe. 2020.

IQVIA Institute for Human Data Science. 15+ years of biosimilar experience in Europe—omnitrope case study. 2022.

Vogler S. How large are the differences between originator and generic prices? Analysis of five molecules in 16 European countries. Farmeconomia Health Econ Ther Pathw. 2012;13:29–41.

Article  Google Scholar 

Moorkens E, Vulto AG, Huys I, Dylst P, Godman B, Keuerleber S, et al. Policies for biosimilar uptake in Europe: an overview. PLoS ONE. 2017;12:e0190147.

Article  PubMed  PubMed Central  Google Scholar 

World Bank. Current health expenditure (% of GDP)—Italy, Brazil, Colombia, Australia, Argentina. 2019. https://data.worldbank.org/indicator/SH.XPD.CHEX.GD.ZS?intcid=ecr_hp_BeltC_en_ext&locations=IT-BR-CO-AU-AR. Accessed 2 May 2023.

Alnaqbi KA, Bellanger A, Brill A, Castañeda-Hernández G, Clopés Estela A, Delgado Sánchez O, et al. An international comparative analysis and roadmap to sustainable biosimilar markets. Front Pharmacol. 2023;14:1188368.

Article  PubMed  PubMed Central  Google Scholar 

Hasan SS, Kow CS, Dawoud D, Mohamed O, Baines D, Babar Z-U-D. Pharmaceutical policy reforms to regulate drug prices in the Asia Pacific region: the case of Australia, China, India, Malaysia, New Zealand, and South Korea. Value Health Reg Issues. 2019;18:18–23.

Article  PubMed  Google Scholar 

Vogler S. PPRI Pharma Brief: Italy 2021. Pharmaceutical pricing and reimbursement information (PPRI) pharma briefs series. Gesundheit Österreich (GÖG / Austrian National Public Health Institute). 2021 https://jasmin.goeg.at/1885/1/PPRI_Pharma_Brief_Italy_2021_final_bf.pdf. Accessed 2 May 2023.

Ribeiro AA, Acosta A, Pontes MA, Machado Beltran MA, Peixoto RT, Leite SN. Transparency of data on the value chain of medicines in Argentina, Brazil, and Colombia. Front Pharmacol. 2023;13:1063300.

Article  PubMed  PubMed Central  Google Scholar 

ANMAT, Administración Nacional de Medicamentos, Alimentos y Tecnología Médica. Vademécum Nacional de Medicamentos. https://servicios.pami.org.ar/vademecum/views/consultaPublica/listado.zul.

Agência Nacional de Vigilância Sanitária. Lista de preços de medicamentos. http://portal.anvisa.gov.br/listas-de-precos.

Farmadati Italia. Banche Dati del Farmaco, Parafarmaco e Dispositivo Medico. https://www.farmadati.it/.

Australian Government, Department of Health and Aged Care. Schedule of pharmaceutical benefits. https://www.pbs.gov.au/info/publication/schedule/archive. Accessed 13 May 2023.

Acosta A, Basto S, Fonseca MF, Duran C, Vargas C, Rovira J. description of drug pricing and procurement information web portals in some Latin American Countries. Pharmacoeconomics Open Access. 2018. https://www.omicsonline.org/open-access/description-of-drug-pricing-and-procurement-information-web-portals-in-some-latin-american-countries-2472-1042-1000116-101781.html. Accessed 17 Mar 2023.

Kakkar AK. Pharmaceutical price regulation and its impact on drug innovation: mitigating the trade-offs. Expert Opin Ther Pat. 2021;31:189–92.

Article  CAS  PubMed  Google Scholar 

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;12:625296.

Article  PubMed  PubMed Central  Google Scholar 

Vargas V, Rama M, Singh R. Pharmaceuticals in Latin America and the Caribbean Players, access, and innovation across diverse models. World bank. 2022. https://openknowledge.worldbank.org/server/api/core/bitstreams/353c099b-8aae-58f5-8a6d-c07eef593556/content. Accessed 17 Mar 2023.

Australian Government, Department of Health and Aged Care. Fact sheet – Setting an approved ex-manufacturer price for new or extended listings. 2017. https://www.pbs.gov.au/info/industry/pricing/pbs-items/fact-sheet-setting-an-approved-ex-manufacturer-price#:~:text=Reference%20pricing%20is%20a%20Government,the%20PBAC%20as%20cost%2Dminimised. Accessed 16 Jun 2023.

Australian Government, Department of Health and Aged Care. Pricing matters. 2023. https://www.pbs.gov.au/info/industry/pricing. Accessed 13 May 2023.

Brasil, Câmara de Regulação do Mercado de Medicamentos. Comunicado no 09, de 10 de agosto de 2016. Divulga decisão do CTE sobre os critérios de precificação de medicamentos biológicos não novos. https://www.gov.br/anvisa/pt-br/assuntos/medicamentos/cmed/legislacao/arquivos/arquivos/6078json-file-1. Accessed 17 Mar 2023.

dos Dias LLS, dos Santos MAB, Pinto CDBS. Regulação contemporânea de preços de medicamentos no Brasil - uma análise crítica. Saúde Em Debate. 2019;43:543–58.

Article  Google Scholar 

Miziara NM, Coutinho DR. Problems in the regulatory policy of the drug market. Rev Saúde Pública. 2015. https://doi.org/10.1590/S0034-8910.2015049005779.

Article  PubMed  PubMed Central  Google Scholar 

de Souza CMA, Paranhos J, Hasenclever L. Comparativo entre preço máximo ao consumidor de medicamentos e preços praticados na internet no Brasil: desalinhamentos e distorções regulatórias. Ciênc Saúde Coletiva. 2021;26:5463–80.

Article  Google Scholar 

IQVIA Institute for Human Data Science. Advancing biosimilar sustainability in Europe—a multi-stakeholder assessment. 2018.

Abdel Rida N, Mohamed Ibrahim MI, Babar Z-U-D, Owusu Y. A systematic review of pharmaceutical pricing policies in developing countries. J Pharm Health Serv Res. 2017;8:213–26.

Article  Google Scholar 

Moye-Holz D, Vogler S. Comparison of prices and affordability of cancer medicines in 16 countries in Europe and Latin America. Appl Health Econ Health Policy. 2022;20:67–77.

Article  PubMed  Google Scholar 

Luukkanen SV, Tolonen HM, Airaksinen M, Saarukka LSM. The price and market share evolution of the original biologics and their biosimilars in finland. BioDrugs. 2022;36:537–47.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Ferrario A, Dedet G, Humbert T, Vogler S, Suleman F, Pedersen HB. Strategies to achieve fairer prices for generic and biosimilar medicines. BMJ. 2020. https://doi.org/10.1136/bmj.l5444.

Article  PubMed  Google Scholar 

Convertino I, Lucenteforte E, Gini R, Lorenzoni V, Cazzato M, Turchetti G, et al. Utilisation patterns and clinical impact of the introduction of infliximab-biosimilar in Tuscany, Italy: real world evidence following the recommendation of switching for non-medical reasons. Clin Exp Rheumatol. 2021;39:753–62.

Article  PubMed  Google Scholar 

Brian G, Biljana T, Eleonora A, Magdalene W, Stuart M, Amanj K, et al. Biosimilars are essential for sustainable healthcare systems; however, key challenges remain as seen with long-acting insulin analogues. J Appl Pharm Sci. 2022. https://doi.org/10.7324/JAPS.2022.120306.

Article  Google Scholar