References
- Nowicki M. Basic facts about biosimilars. Kidney Blood Press Res. 2007;30(5):267–6. doi:10.1159/000105133.
- NHS. Biosimilar medicines. (UK); 2023. https://www.england.nhs.uk/medicines-2/biosimilar-medicines/.
- Pfizer. How access to biosimilar drugs could boost healthcare equity [internet]. 2022 [accessed 2024 Mar 12]. https://www.pfizer.com/news/articles/how_access_to_biosimilar_drugs_could_boost_healthcare_equity.
- FDA. Biosimilars and interchangeable biosimilars. USA: FDA; 2023.
- EMA. Biosimilar medicines: overview. European Union, Amsterdam: European Medicines Agency; 2023.
- Niazi SK. Biosimilars: harmonizing the approval guidelines. Biol. 2022 Jul;2(3):171–95. doi:10.3390/biologics2030014.
- WHO. Guidelines on evaluation of biosimilars. Replacement of Annex 2 of WHO technical report series, No. 977. World Health Organization: Geneve, Switzerland; 2022.
- Niazi SK. Opinion: one step forward, half a step back for WHO biosimilar guidance. 2021. https://www.centerforbiosimilars.com/view/opinion-one-step-forward-half-a-step-back-for-who-biosimilar-guidance.
- Generics and Biosimilar Initiative. Guidelines for biosimilars around the world. 2018. https://www.gabionline.net/reports/Guidelines-for-biosimilars-around-the-world.
- Niazi SK, Al-Shaqha WM, Mirza Z. Proposal of international council for harmonization (ICH) guideline for the approval of biosimilars. J Mark Access Health Policy. 2023 Dec;11(1):2147286. doi:10.1080/20016689.2022.2147286.
- GENDEDGE. The unbearable cost of drug development: Deloitte report shows 15% jump in R&D to $2.3 billion [Internet]. 2023 [accessed 2024 Mar 12]. https://www.genengnews.com/gen-edge/the-unbearable-cost-of-drug-development-deloitte-report-shows-15-jump-in-rd-to-2-3-billion/.
- Mascarenhas-Melo F, Diaz M, Gonçalves MBS, Vieira P, Bell V, Viana S, Nunes S, Paiva-Santos AC, Veiga F. An overview of biosimilars—development, quality, regulatory issues, and management in healthcare. Pharmaceutic [Internet]. 2024;17(2):235. doi:10.3390/ph17020235.
- World Health Organization [Internet]. Guidelines on evaluation of similar biotherapeutic products (SBPs), Annex 2, TRS No 977. Geneve, Switzerland: World Health Organization; 2010.
- Kang HN, Thorpe R, Knezevic I, Blades CDRZ, Casas Levano M, Chew JY, Chilufya MB, Chirachanakul P, Chua HM, Farahani AV, et al. The regulatory landscape of biosimilars: WHO efforts and progress made from 2009 to 2019. Biological. 2020 May;65:1–9. doi:10.1016/j.biologicals.2020.02.005.
- Kang HN. Summary of the diverse situation of similar biotherapeutic products in the selected countries (August 2010). Biological. 2011 Sep;39(5):304–7. doi:10.1016/j.biologicals.2011.08.007.
- European Medicines Agency (EMA). Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. Amsterdam: EMA; 2015.
- European Commission. What you need to know about biosimilar medicinal products - a consensus information document. European Union, Luxembourg; 2015.
- Knezevic I, Griffiths E. WHO standards for biotherapeutics, including biosimilars: an example of the evaluation of complex biological products. Ann N Y Acad Sci. 2017 Nov;1407(1):5–16. doi:10.1111/nyas.13434.
- Veronica Salib. Regulating and authorizing medicines: A comparison of the FDA and EMA [Internet]. 2023 [accessed 2024 Mar 13]. https://pharmanewsintel.com/features/regulating-and-authorizing-medicines-a-comparison-of-the-fda-and-ema.
- FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases [Internet]. 2023 [aceessed 2024 Mar 12]. https://www.fda.gov/news-events/press-announcements/fda-approves-interchangeable-biosimilar-multiple-inflammatory-diseases.
- De Kaushik. Impact of biosimilars on treatment landscape in US and EU [internet]. 2023 [accessed 2024 Jan 23]. https://www.aranca.com/knowledge-library/articles/business-research/impact-of-biosimilars-on-treatment-landscape-in-us-and-eu.
- Pharma Ddr. Biosimilarity and interchangeability in the MENA region [internet]. 2022 [accessed 2024 Mar 22]. https://resource.ddregpharma.com/insights/biosimilarity-and-interchangeability-in-the-mena-region/.
- International Regulatory Harmonization | FDA. 2020. https://www.fda.gov/drugs/cder-international-program/international-regulatory-harmonization#:~:text=ICH’s%20mission%20is%20to%20achieve,the%20most%20resource%2Defficient%20manner.
- Kang HN, Thorpe R, Knezevic I, Casas Levano M, Chilufya MB, Chirachanakul P, Chua HM, Dalili D, Foo F, Gao K, et al. Regulatory challenges with biosimilars: an update from 20 countries. Ann N Y Acad Sci. 2021 May;1491(1):42–59. doi:10.1111/nyas.14522.
- de la Méndez M, Trejo AH. Barriers and challenges for global regulatory harmonization. 2020. https://informaconnect.com/barriers-global-regulatory-harmonization/.
- Alami H, Rivard L, Lehoux P, Ag Ahmed MA, Fortin JP, Fleet R. Integrating environmental considerations in digital health technology assessment and procurement: stakeholders’ perspectives. Digit Heal [Internet]. 2023 Jan 1;9:20552076231219110. doi:10.1177/20552076231219113.
- de Ascef BO, de Lopes AC, de Soárez PC. Health technology assessment of biosimilars worldwide: a scoping review. Health Res Policy Sys. 2020;18(1):95. doi:10.1186/s12961-020-00611-y.
- Ball G, Levine MAH, Thabane L, Tarride JE. Appraisals by health technology assessment agencies of economic evaluations submitted as part of reimbursement dossiers for oncology treatments: evidence from Canada, the UK, and Australia. Curr Oncol [Internet]. 2022;29(10):7624–36. doi:10.3390/curroncol29100602.
- AJMC. 3 key considerations for implementing biosimilars in health systems [internet]. 2018 [accessed 2024 Mar 12]. https://www.centerforbiosimilars.com/view/3-key-considerations-for-implementing-biosimilars-in-health-systems.
- US FDA. Multimedia education materials | biosimilars [internet]. 2024. https://www.fda.gov/drugs/biosimilars/multimedia-education-materials-biosimilars.
- Oskouei ST, Kusmierczyk AR. Biosimilar uptake: the importance of healthcare provider education. Pharmaceut Med. 2021 Jul;35(4):215–24. doi:10.1007/s40290-021-00396-7.