References
- WHO. Towards access 2030 WHO medicines and health products programme strategic framework 2016-2030. World Health Organization 2017. Available from: https://www.who.int/medicines/publications/Towards_Access_2030_Final.pdf. cited1Dec 2021.
- Declerck P, Danesi R, Petersel D, et al. The language of biosimilars: clarification, definitions, and regulatory Aspects. Drugs. 2017;77(6):671–677.
- Singh SC, Bagato KM. The economic implications of biosimilars. Am J Manag Care. 2015;21(16 Suppl):S331–40.
- Linker R. Biosimilars market by product, manufacturing & indication, region – global forecast to 2025. 2020. Available from: https://www.reportlinker.com/p04604343/Biosimilars-Market-by-Product-Manufacturing-Application-Global-Forecast-to.html?utm_source=GNW. Accessed 2020 Sep 11.
- Chen Y, Lehmann A, Santos da Silva J What’s next for biosimilars in emerging markets? McKinsey & company 2019. Available from https://www.mckinsey.com/industries/life-sciences/our-insights/whats-next-for-biosimilars-in-emerging-markets. cited 2021 Dec 1.
- World Health Organization Global Health Expenditure Database Out-of-pocket expenditure (% of current health expenditure) Available from: https://data.worldbank.org/indicator/SH.XPD.OOPC.CH.ZS?most_recent_value_desc=true. cited 2021 Dec 1.
- The World Bank Data. Available from: http://databank.worldbank.org/data/home.aspx. cited 2022 Mar 10.
- Arokiasamy P, Uttamacharya KP, Kowal P, et al. Chronic noncommunicable diseases in 6 low- and middle-income countries: findings from wave 1 of the world health organization’s study on global ageing and adult health (SAGE). Am J Epidemiol. 2017;185(6):414–428.
- Bray F, Jemal A, Grey N, et al. Global cancer transitions according to human development index (2008-2030): a population based study. Lancet Oncol. 2012;13(8):790–801.
- The World Bank Data. Diabetes prevalence (% of population ages 20 to 79) international diabetes federation, diabetes atlas. Available from: https://data.worldbank.org/indicator/SH.STA.DIAB.ZS. cited 2021 Dec 1.
- World Health Organization. Global health estimates summary tables: projection of deaths by cause, age and sex, by world bank income category and WHO region. 2013. Available from:http://www.who.int/healthinfo/global_burden_disease/GHE_DthWHOReg7_Proj_2015_2030.xls?ua=1. cited 2016 Mar 28.
- Samb B, Desai N, Nishtar S, et al. Prevention and management of chronic disease: a litmus test for health-systems strengthening in low-income and middle-income countries. Lancet. 2010;376(9754):1785–1797.
- EMA. Guideline On Similar Biological Medicinal Products. 2005. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-first-version_en.pdf. cited 2020 Aug 10.
- Moore TJ, Mouslim MC, Blunt JL, et al. Assessment of availability, clinical testing, and US food and drug administration review of biosimilar biologic products. JAMA Intern Med. 2021;181(1):52–60.
- US FDA. Scientific considerations in demonstrating biosimilarity to a reference product guidance for industry. 2015. https://www.fda.gov/media/82647/download. cited 2020 Sep 11.
- de Assis MR, Pinto V. Strengths and weaknesses of the Brazilian regulation on biosimilars: a critical view of the regulatory requirements for biosimilars in Brazil. Ther Adv Musculoskelet Dis. 2018;10(12):253–259.
- Shekhar R, Hallur N, Muralidharan P, et al. Regulatory pathway for registration of biosimilars in Russia. Asian J Pharm Res Dev. 1970;8(2):79–87.
- Rathore AS, Bhargava A. Regulatory considerations in biosimilars: Asia Pacific regions. Prep Biochem Biotechnol. 2021;51(1):1–8.
- Hagen T China pulls out stops for biosimilar development. The Center for Biosimilars. 2021. Available from: https://www.centerforbiosimilars.com/view/china-pulls-out-stops-for-biosimilar-development. Accessed on 2021 Dec 1.
- SAHPRA. Biosimilar medicines quality, non-clinical and clinical requirements. South African Health Product Regulatory Authority. 2014. Available from https://www.sahpra.org.za/wp-content/uploads/2020/04/SAHPRA-Biosimilar-Medicines-Guidance_Aug14_v3.pdf. Accessed on 2021 Dec 1.
- Lopez-Morales CA, Tenorio- Calvo A, Cruz-Rodríguez R, et al. Regulatory pathway for licensing biotherapeutics in Mexico. Front Med. 2018;5:272.
- Wardiana A, Ningrum RA. The emergence of Biosimilars in Indonesia: guidelines, challenges and prospects. InAnnales Bogorienses. 2016;20(2):37–46.
- Rathore AS, Bhargava A. Biosimilar in developed economies: overview, status and regulatory considerations. Regul Toxicol Pharmacol. 2020;110:104525.
- Rathore AS, Bhargava A. Regulatory considerations in biosimilars: middle East and Africa regions. Prep Biochem Biotechnol. 2021;51(8):731–737.
- WHO Expert Committee on Biological Standardization. Annex 3. Regulatory assessment of approved rDNA derived biotherapeutics. WHO Technical Report Series no. 999. 2016. Accessed on 2020 August 19.
- Pagani E. Why are biosimilars much more complex than generics? Einstein (Sao Paulo. Einstein (Sao Paulo, Brazil). 2019;17(1): Eed4836. DOI: 10.31744/einstein_journal/2019ED4836.
- Blackstone EA, Fuhr JP. The economics of biosimilars. Am Heal Drug Benefits. 2013;6(8):469–477.
- Rahalkar H, Sheppard A, Santos GML, et al. Current regulatory requirements for biosimilars in six member countries of BRICS-TM: challenges and opportunities. Front Med (Lausanne). 2021;8:726660.
- Rahalkar H, Sheppard A, Morales CA L, et al. Challenges faced by the biopharmaceutical industry in the development and marketing authorization of biosimilar medicines in BRICS-TM countries: an exploratory study. Pharm Med. 2021;35(4):235–251.
- Druedahl LC, Almarsdottir AB, Sporrong SK, et al. A qualitative study of biosimilar manufacturer and regulator perceptions on intellectual property and abbreviated approval pathways. Nature Biotech. 2020;38(11):1253–1256.
- Van de Wiele VL, Beall RF, Kesselheim AS, et al. The characteristics of patents impacting availability of biosimilars. Nature Biotech. 2022;40(1):22–25.
- Zhai MZ, Sarpatwri A, Kesselheim AS. Why are biosimilars not living up to their promise in the US? AMA J Ethics. 2019;21(8):E668–678.
- Tridico A, Jacobstein J, Wall L Facilitating generic drug manufacturing: bolar exemptions worldwide. WIPO Magazine 2014. Accessed on 2022 Apr 12.
- Moorkens E, Vulto G, Huys A, et al. Policies for biosimilar uptake in Europe: an overview. PLoS One. 2017;12(12):e0190147. 28.
- Remuzat C, Kapusniak A, Caban A, et al. Supply-side and demand-side policies for biosimilars: an overview in 10 European member states. J Mark Access Health Policy. 2017;5(1):1307315.
- Vogler S, Schneider P, Zuba M, et al. Policies to encourage the use of biosimilars in European countries and their potential impact on Pharmaceutical expenditure. Front Pharmacol. 2021;12:625296.
- Kim Y, Kwon HY, Godman B, et al. Uptake of biosimilar infliximab in the UK, France, Japan, and Korea: budget savings or market expansion across countries? Front Pharmacol. 2020;11:970.
- World Health Organization. WHO guideline on country pharmaceutical pricing policies. 2020.
- Espin J, Rovira J, Ewen M, et al. Working paper mapping external reference pricing practices for medicines. 2014. Available from: http://haiweb.org/wp-content/uploads/2015/10/ERP-Working-Paper.pdf. Accessed 2020 Aug 10.
- Nguyen TA, Knight R, Roughead EE, et al. Policy options for pharmaceutical pricing and purchasing: issues for low- and middle-income countries. Health Policy Plan. 2015;30(2):267–280.
- Team P “Who wants the biggest slice of the biosimilar pie?”: the humira biosimilar wave in Europe Internet. Eversana. 2019 Available from:https://www.eversana.com/insights/who-wants-the-biggest-slice-of-the-biosimilar-pie-the-humira-biosimilar-wave-in-europe/. cited 2020 Aug 10.
- Wouters OJ, Sandberg DM, Pillay A, et al. The impact of pharmaceutical tendering on prices and market concentration in South Africa over a 14-year period. Soc Sci Med. 2019;220:362–370.
- Anggriani Y, Ramadaniati HU, Sarnianto P, et al., The imact of pharmaceutical policies on medicine procurment pricing in Indonesis under the implementation of Indonesia’s social health insurance system. 2020;Val Health Regional Issues. 21:1–8.
- Dranitsaris G, Jacobs I, Kirchhoff C, et al. Drug tendering: drug supply and shortage implications for the uptake of biosimilars. Clinicoecon Outcomes Res. 2017;9:573–584.
- EuropaBio.2015 white paper on public procurement of biological medicines. Available from:https://www.europabio.org/sites/default/files/europabio_white_paper_on_public_procurement_of_biological_medicines_final.pdf. Accessed 2020 Aug 10.
- Cohen H, Beydoun D, Chien D, et al. Awareness, knowledge, and perceptions of biosimilars among specialty physicians. Adv Ther. 2017;33(12):2160–2172.
- Sarnola K, Merikoski M, Jyrkka J, et al. Physicians’ perceptions of the uptake of biosimilars: a systematic review. BMJ Open. 2020;10(5):e034183.
- Boswell E, Johnson P, Bond AM. Physician, practice and patient characteristics associated with biosimilar use in medicare recipients. JAMA Network Open. 2021;4(1):e2034776.
- Teeple AT, Ellis L, Huff L, et al. Physician attitudes about non-medical switching to biosimilars: results from an online physician survey in the United States. Curr Med Res Opin. 2019;35(4):611–617.
- Waller J, Sullivan E, Piercy J, et al. Assessing physician and patient acceptance of infliximab biosimilars in rheumatoid arthritis, ankylosing spondyloarthritis and psoriatic arthritis across Germany. Patient Prefer Adherence. 2017;11:519–530.
- Sullivan E, Piercy J, Waller J, et al. Assessing gastroenterologist and patient acceptance of biosimilars in ulcerative colitis and Chron’s disease across Germany. Plos One. 2017;12(4):e0175826.
- Grabowski D, Henderson B, Lam D, et al. Attitudes towards subsequent entry biologics/biosimilars: a survey of Canadianrheumatologists. Clin Rheumatol. 2015;34(8):1427–1433.
- D’Amico F, Pouillon L, Argollo M, et al. Multidisciplinary management of the nocebo effect in biosimilar-treated IBD patients: results of a workshop from the NOCE-BIO consensus group. Dig Liv Dis. 2020;52(2):138–142.
- Karateev D, Belokoneva N. Evaluation of physicians’ knowledge and attitudes towards biosimilars in Russia and issues associated with their prescribing. Biomolecules. 2019;9(2):57.
- Garcia KS, Facas BP, Machado MB, et al. Biosimilar knowledge and viewpoints among Brazilian inflammatory bowel disease patients. Therap Adv Gastroenterol. 2021;14:1–11.
- Vogler S, Paris V, Ferrario A, et al. How can pricing and reimbursement policies improve affordable access to medicines? lessons learned from European countries. Appl Health Econ Health Policy. 2017;15(3):307–321.
- Remuzat C, Dorey J, Cristeau O, et al. Key drivers for market penetration of biosimilars in Europe. J Mark Access Health Policy. 2017;5(1):1272308.
- Khan D, Luig T, Mosher D, et al. Lessons from international experience with biosimilar implementation: an application of the diffusion of innovations model. Health Pol. 2020;15(3):16–27.
- Reilly MS, Schneider PJ. Policy recommendations for a sustainable biosimilars market: lessons from Europe. GaBI J. 2020;9(2):76–83.
- Generics and Biosimilar initiative. Strategic biologicals alliance between sanofi and JHL biotech in China. GaBi. Available from: https://www.gabionline.net/pharma-news/Strategic-biologicals-alliance-between-Sanofi-and-JHL-Biotech-in-China. cited 2021 Dec 1.
- Generics and Biosimilar initiative. Amgen and Simcere to collaborate on copy biologicals in China GaBi. Available from: https://www.gabionline.net/pharma-news/Amgen-and-Simcere-to-collaborate-on-copy-biologicals-in-China. cited 2021 Dec 1.
- The Center for Biosimilars Staff. Eye on pharma: samsung bioepis to partner with 3SBio on biosimilars. the center for biosimilars. Available from: https://www.centerforbiosimilars.com/view/eye-on-pharma-samsung-bioepis-to-partner-with-3sbio-on-biosimilars. cited 2021 Dec 1.
- The Center for Biosimilars Staff. Eye on pharma: samsung bioepis to partner with C-bridge on biosimilars. the center for biosimilars. Available from: https://www.centerforbiosimilars.com/view/eye-on-pharma-samsung-bioepis-to-partner-with-cbridge-on-biosimilars. cited 2021 Dec 1.
- In Vivo Informa Pharma Intelligence. Alvotech reels in abdi ibrahim for access to Turkey. Informa PLC Available from: https://invivo.pharmaintelligence.informa.com/GB140400/Alvotech-Reels-In-Abdi-Ibrahim-For-Access-To-Turkey cited 2021 Dec 1.
- Biopharm International Editors. ProBioGen and bio farma plan Indonesian production of trastuzumab. Biopharm International. Availabe from: https://www.biopharminternational.com/view/probiogen-and-bio-farma-plan-indonesian-production-trastuzumab. cited 2021 Dec 1.
- Generics and Biosimilar initiative. Innovent makes deal for bevacizumab copy biological in Indonesia. GaBi. Available from: https://www.gabionline.net/pharma-news/Innovent-makes-deal-for-bevacizumab-copy-biological-in-Indonesia. cited 2021 Dec 1.
- wire B. Bio-thera solutions expands partnership with pharmapark in Russia and other CIS Countries with addition of BAT2206, a Stelara® Biosimilar Availabe from: https://www.businesswire.com/news/home/20211015005249/en/Bio-Thera-Solutions-Expands-Partnership-with-Pharmapark-in-Russia-and-other-CIS-Countries-with-Addition-of-BAT2206-a-Stelara%C2%AE-Biosimilar. cited 2021 Dec 1.
- Hagen T Prestige biopharma sets up second Russian distribution deal. the center for biosimilars. Available from: https://www.centerforbiosimilars.com/view/prestige-biopharma-sets-up-second-russian-distribution-deal. cited 2021 Dec 1.
- Jeremias S Alvotech and Cipla Partner on 5 biosimilars for South Africa. the center for biosimilars. Available from: https://www.centerforbiosimilars.com/view/alvotech-and-cipla-partner-on-5-biosimilars-for-south-africa. cited 2021 Dec 1.
- Generics and biosimilar initiative biocon partners with Libbs for the sale of generics in Brazil. GaBi. Available from: https://www.gabionline.net/pharma-news/Biocon-partners-with-Libbs-for-the-sale-of-generics-in-Brazil. cited 2021 Dec 1.
- Jacob J How mylan used partnering deals to become a key player in biosimilars internet. Biosimilar Development. 2018. Available from: https://www.biosimilardevelopment.com/doc/how-mylan-used-partnering-deals-to-become-a-key-player-in-biosimilars-0001. cited 2021 Dec 1.
- Generics and biosimilar initiative mylan and lupin make deal for etanercept biosimilar. GaBi. Available from: https://www.gabionline.net/pharma-news/Mylan-and-Lupin-make-deal-for-etanercept-biosimilar. cited 2021 Dec 1.
- Generics and Biosimilar initiative. Epirus and ranbaxy sign agreement for infliximab ‘similar biologic’ GaBi. Available from: https://www.gabionline.net/biosimilars/news/Epirus-and-Ranbaxy-sign-agreement-for-infliximab-similar-biologic. cited 2021 Dec 1.
- Biopharm International Editors. Apotex and Intas to Develop Biosimilar of PegfilgrastimBiopharm International. Availabe from: https://www.biopharminternational.com/view/apotex-and-intas-develop-biosimilar-pegfilgrastim. cited 2021 Dec 1.
- Rathore AS, Shareef F. The influence of domestic manufacturing capabilities on biologic pricing in emerging economies. Nat Biotechnol. 2019;37(5):498–501.
- Ministry of Food and Drug Safety. Republic of Korea. biosimilar. Available from: https://www.mfds.go.kr/eng/wpge/m_37/de011024l001.do. cited 2021 Dec 1.
- The Korea Herald. Korea to promote biosimilar industry. Available from: http://www.koreaherald.com/view.php?ud=20101118000933. cited 2021 Dec 1.
- Hagen T Celltrion dominates Republic of Korea drug exports, targets latin america the center for biosimilars. Available from: https://www.centerforbiosimilars.com/view/celltrion-dominates-republic-of-korea-drug-exports-targets-latin-america. cited 2021 Dec 1.
- Korean biopharmaceuticals: anchor report. Nomura Equity Research.2014. Available from: https://www.nomura.com/europe/resources/upload/Korean_biopharmaceuticals.pdf. cited 2020 Sept 16.
- Rak Tkaczuk KH, Jacobs IA. Biosimilars in oncology: from development to clinical practice. Semin Oncol. 2014;41(SUPPL.3):S3–12.
- Mysler E, Pineda C, Horiuchi T, et al. Clinical and regulatory perspectives on biosimilar therapies and intended copies of biologics in rheumatology. Rheumatol Int. 2016;36(5):613–625.
- Generics and Biosimilar initiative. EMA approval for biosimilar insulin glargine Semglee GaBi. Available from: https://www.gabionline.net/biosimilars/news/EMA-approval-for-biosimilar-insulin-glargine-Semglee. cited 2021 Dec 1.
- Generics and Biosimilar initiative. FDA approves insulin glargine biosimilar SemgleeGaBi. Available from: https://www.gabionline.net/biosimilars/news/FDA-approves-insulin-glargine-biosimilar-Semglee. cited 2021 Dec 1.
- Scheinberg MA, Felix PAO, Kos IA, et al. Partnership for productive development of biosimilar products: perspectives of access to biological products in the Brazilian market. Einstein (Sao Paulo). 2018;16(3):eRW4175.
- Rahalkar H, Sheppard A, Salek S. Biosimilar development and review process in the BRICS-TM countries: proposal for a standardized model to improve regulatory performance. Expert Rev Clinical Pharmacology. 2022;15(2). DOI:10.1080/17512433.2022.2034498.