References
- EvaluatePharma® world preview 2020, outlook to 2026 [Internet]. Evaluate; 2020. Available from: https://info.evaluate.com/EvaluatePharma-World-Preview-2020.html
- Medicine use and spending in the U.S.: a review of 2017 and outlook to 2022 [Internet]. IQVIA Institute for Human Data Science; 2018. Available from: https://www.iqvia.com/insights/the-iqvia-institute/reports/medicine-use-and-spending-in-the-us-review-of-2017-outlook-to-2022
- Giuliani J, Bonetti A. The economic impact of biosimilars in oncology and hematology: the case of trastuzumab and rituximab. Anticancer Res. 2019;39:3971.
- Giuliani J, Fiorica F, Albanese V, et al. Financial toxicity and cancer treatments: help from biosimilars - The explanatory case of bevacizumab. Eur J Cancer. 2021;143:40–42.
- Guidance document: quality considerations in demonstrating biosimilarity of a therapeutic protein product to a reference product guidance for industry [Internet]. U.S. Food and Drug Administration; 2015. Available from: https://www.fda.gov/media/135612/download
- Biosimilar medicines: overview [Internet]. European Medical Agency. [cited 2022 Apr 5]. Available from: https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines-overview#:~:text=in%20the%20EU-,A%20biosimilar%20is%20a%20biological%20medicine%20highly%20similar%20to%20another,medicines%20to%20cause%20an%20immune
- FDA-Approved biosimilar products [Internet]. Food and Drug Administration; 2022 [cited 2022 Apr 5]. Available from: https://www.fda.gov/drugs/biosimilars/biosimilar-product-information
- Details of biosimilars approved in the Europe till 31-December-2021, European medicines agency [Internet]. European Medicines Agency. [cited 2022 Apr 5]. Available from: https://www.ema.europa.eu/en/medicines/field_ema_web_categories%253Aname_field/Human/ema_group_types/ema_medicine/field_ema_med_status/authorised-36/ema_medicine_types/field_ema_med_biosimilar/field_ema_web_categories%253Aname_field/Human/search_api_aggregation_ema_medicine_types/field_ema_med_biosimilar/field_ema_computed_date_field/%5B%2A%20TO%202021-12-31T22%3A59%3A59Z%5D/ema_group_types/ema_medicine
- How the U.S. Compares to Europe on biosimilar approvals and products in the pipeline [Internet]. JD Supra; 2022 [cited 2022 Apr 5]. Available from: https://www.jdsupra.com/legalnews/how-the-u-s-compares-to-europe-on-7635750/
- An inflection point for biosimilars [Internet]. McKinsey & Company; 2021. Available from: https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/an-inflection-point-for-biosimilars
- Biosimilars in the United States 2020–2024 [Internet]. The IQVIA Institute; 2020. Available from: https://www.iqvia.com/insights/the-iqvia-institute/reports/biosimilars-in-the-united-states-2020-2024
- Emerging health care issues: follow-on biologic drug competition [Internet]. Federal Trade Commission; 2009. Available from: https://www.ftc.gov/sites/default/files/documents/reports/emerging-health-care-issues-follow-biologic-drug-competition-federal-trade-commission-report/p083901biologicsreport.pdf
- 2020 biosimilar trends report [Internet]. Amgen Biosimilars. Available from: https://www.amgenbiosimilars.com/-/media/Themes/Amgen/amgenbiosimilars-com/Amgenbiosimilars-com/pdf/USA-CBU-80723-2020-Amgen-Biosimilar-Trends-Report.pdf
- Bode-Greuel K, Greuel J. Determining the value of drug development candidates and technology platforms. J Commer Biotechnol. 2005;11:155–170.
- Nickisch K, Bode-Greuel K. NPV modeling for the selection of value creating biosimilar development candidates. J Commer Biotechnol. 2013;19:24–32
- Bode-Greuel KM, Nickisch K. Deciding between biobetter versus biosimilar development options based on net present value calculations. J Commer Biotechnol. 2014;20:21–31.
- Prescribing information, Nucala® (mepolizumab) for injection and injection, for subcutaneous use [Internet]. U.S. Food and Drug Administration; 2020. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125526s017lbl.pdf
- Prescribing information, Dupixent® (dupilumab) injection, for subcutaneous use [Internet]. U.S. Food and Drug Administration; 2021. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761055s016lbl.pdf
- Prescribing information, Cosentyx® (secukinumab) for injection and injection, for subcutaneous use [Internet]. U.S. Food and Drug Administration; 2021. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125504s043lbl.pdf
- Prescribing information, Stelara® (ustekinumab) injection, for subcutaneous or intravenous use [Internet]. U.S. Food and Drug Administration; 2020. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125261s154,761044s006lbl.pdf
- Guidance document: reference product exclusivity for biological products filed under section 351(a) of the PHS act [Internet]. U.S. Food and Drug Administration; 2014. Available from: https://www.fda.gov/media/89049/download
- Ribeiro S. Data exclusivity, market protection, orphan and paediatric rewards [Internet]. European Medicines Agency; 2018. Available from: https://www.ema.europa.eu/en/documents/presentation/presentation-data-exclusivity-market-protection-orphan-paediatric-rewards-s-ribeiro_en.pdf
- Biosimilar biological product reauthorization performance goals and procedures fiscal years 2018 through 2022 [Internet]. U.S. Food and Drug Administration. Available from: https://www.fda.gov/media/100573/download
- Five things to know about biosimilars right now [Internet]. McKinsey Co; 2018. Available from: https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/five-things-to-know-about-biosimilars-right-now
- Winning with biosimilars: opportunities in global markets [Internet]. Deloitte; 2015. Available from: https://www2.deloitte.com/content/dam/Deloitte/us/Documents/life-sciences-health-care/us-lshc-biosimilars-whitepaper-final.pdf
- 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;181:52–60
- Biosimilar user fee amendments and user fee rates for FY 2021 and FY 2022 [Internet]. 2021 [cited 2021 Oct 29]. Available from: https://www.fda.gov/industry/fda-user-fee-programs/biosimilar-user-fee-amendments
- Explanatory note on general fees payable to the European medicines agency [Internet]. European Medicines Agency; 2022. Available from: https://www.ema.europa.eu/en/documents/other/explanatory-note-general-fees-payable-european-medicines-agency-01-april-2022_en.pdf
- Castle G, Kelly B, Gathani R. Pricing & reimbursement laws and regulations (2021) United Kingdom. Glob Leg Insights [Internet]. Available from: https://www.globallegalinsights.com/practice-areas/pricing-and-reimbursement-laws-and-regulations/united-kingdom#chaptercontent2
- Toumi M, Rémuzat C, Vataire A-L, et al. External reference pricing of medicinal products: simulation-based considerations for cross-country coordination: final report [Internet]. European Commission; 2013. Available from: https://ec.europa.eu/health/system/files/2016-11/erp_reimbursement_medicinal_products_en_2.pdf
- Drug pricing (Postnote 364) [Internet]. Parliamentary Office of Science & Technology. UK; 2010. Available from: https://www.parliament.uk/globalassets/documents/post/postpn_364_Drug_Pricing.pdf
- Urban GL, Carter T, Gaskin S, et al. Market share rewards to pioneering brands: an empirical analysis and strategic implications. Manage Sci. 1986;32:645–659.
- Kalyanaram G. The order of entry effect in prescription (Rx) and over-the-counter (OTC) pharmaceutical drugs. Int J Pharm Healthc. 2008;2:35–46
- Troein P, Newton M, Scott K, et al. The impact of biosimilar competition in Europe. IQVIA; 2021
- 2021 Biosimilar Trends Report. Current state of the market place [Internet]. Amgen Biosimilars; 2021. Available from: https://www.amgenbiosimilars.com/-/media/Themes/Amgen/amgenbiosimilars-com/Amgenbiosimilars-com/pdf/USA-CBU-80961_Amgen-Biosimilars-Trend-Report.pdf
- 2021 ASP drug pricing files [Internet]. Centers for Medicare & Medicaid Services; 2021 [cited 2021 Nov 1]. Available from: https://www.cms.gov/medicare/medicare-part-b-drug-average-sales-price/2021-asp-drug-pricing-files
- Drugs.com. Available from: https://www.drugs.com
- National Health Expenditure (NHE) fact sheet, Centers for Medicare and Medicaid Services [Internet]. Centers for Medicare & Medicaid Services; 2020. Available from: https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/NHE-Fact-Sheet
- Health expenditure per capita (Health at a glance: Europe 2020: state of health in the EU cycle) [Internet]. Organisation for Economic Co-operation and Development OECD Library; [cited 2022 Apr 2]. Available from: https://www.oecd-ilibrary.org/sites/910674f2-en/index.html?itemId=/content/component/910674f2-en
- 2021 global medical trends survey report. Global average medical trends by country, 2019-2021 [Internet]. Willis Towers Watson; 2020. Available from: https://www.willistowerswatson.com/-/media/WTW/Insights/2020/10/2021-global-medical-trends-survey-report-20-sept-v6.pdf?modified=20201014180610
- Getting a grip on COGS in generic drugs [Internet]. Boston Consult. Group BCG; 2019. Available from: https://www.bcg.com/en-in/publications/2019/getting-a-grip-on-cogs-in-generic-drugs
- Basu P, Joglekar G, Rai S, et al. Analysis of manufacturing costs in pharmaceutical companies. J Pharm Innov. 2008;3:30–40
- Peire A, Frei P. What is the value of a deal? [Internet]. 2016 [cited 2021 Sept 22]. Available from: https://www.nature.com/articles/d43747-020-00160-x
- Woo J, Kim E, Sung T-E, et al. Developing an improved risk-adjusted net present value technology valuation model for the biopharmaceutical industry. J Open Innov Technol Mark Complex. 2019;5 .
- Asen E. Corporate tax rates around the world, 2020 [Internet]. The Tax Foundation; 2020 [cited 2021 Sept 25]. Available from: https://files.taxfoundation.org/20201208152358/2020-Corporate-Tax-Rates-around-the-World.pdf
- Inflation, consumer prices (annual %) [Internet]. World Bank; [cited 2022 Apr 2]. Available from: https://data.worldbank.org/indicator/FP.CPI.TOTL.ZG?end=2020&start=2000&view=chart
- Clinical development success rates and contributing factors 2011–2020 [Internet]. Biotechnology Innovation Organization, Informa Pharma Intelligence, QLS Advisors; 2021. Available from: https://pharmaintelligence.informa.com/~/media/informa-shop-window/pharma/2021/files/reports/2021-clinical-development-success-rates-2011-2020-v17.pdf
- Amgen and Astra hope to carve out a place in asthma [Internet]. Evaluate Vantage; 2020 [cited 2021 Sept 15]. Available from: https://www.evaluate.com/vantage/articles/events/company-events/amgen-and-astra-hope-carve-out-place-asthma
- Press release. Press release. Full year and fourth quarter 2020. GSK [Internet]. GSK; 2021 [cited 2021 Sept 15]. Available from: https://www.gsk.com/media/6557/fy-2020-results-announcement.pdf
- EvaluatePharma® world preview 2018, outlook to 2024 [Internet]. Evaluate; 2018. Available from: https://www.evaluate.com/thought-leadership/pharma/evaluatepharma-world-preview-2018-outlook-2024
- Nucala® (Mepolizumab) US price [Internet]. [cited 2021 Sept 22]. Available from: https://www.drugs.com/price-guide/nucala
- Cosentyx® (Secukinumab) US price [Internet]. [cited 2021 Sept 22]. Available from: https://www.cosentyx.com/treatment-cost
- Dupixent® (Dupilumab) US price [Internet]. [cited 2021 Sept 22]. Available from: https://www.dupixent.com/support-savings/cost-insurance
- Nucala® (Mepolizumab) solution for injection pricing (British National Formulary) [Internet]. The National Institute for Health and Care Excellence NICE; [cited 2022 Apr 2]. Available from: https://bnf.nice.org.uk/medicinal-forms/mepolizumab.html
- Cosentyx® (Secukinumab) solution for injection pricing (British National Formulary) [Internet]. The National Institute for Health and Care Excellence NICE. [cited 2022 Apr 2]. Available from: https://bnf.nice.org.uk/medicinal-forms/secukinumab.html
- Dupixent® (Dupilumab) solution for injection pricing (British National Formulary) [Internet]. The National Institute for Health and Care Excellence NICE. [cited 2022 Apr 2]. Available from: https://bnf.nice.org.uk/medicinal-forms/dupilumab.html
- Bio-Thera solutions initiates phase iii clinical trial for BAT2506, a Proposed biosimilar of simponi® (Golimumab) [Internet]. Businesswire; 2021 [cited 2021 Sept 15]. Available from: https://www.businesswire.com/news/home/20210608005454/en/Bio-Thera-Solutions-Initiates-Phase-III-Clinical-Trial-for-BAT2506-a-Proposed-Biosimilar-of-Simponi%C2%AE-Golimumab
- Comparative study to evaluate the pharmacokinetics of BAT2306 vs Cosentyx® in healthy subjects (NCT04711343) [Internet]. Clinicaltrials.gov; 2021 [cited 2021 Sept 15]. Available from: https://clinicaltrials.gov/ct2/show/NCT04711343
- Secukinumab biosimilar - luye pharma group [Internet]. Adis Insight; 2019 [cited 2021 Sept 15]. Available from: https://adisinsight.springer.com/drugs/800056802
- Žižlavskýa O. Net present value approach: method for economic assessment of innovation projects. Procedia - Soc Behav Sci. 2014;156:506–514.
- Stasior J, Machinist B, Esposito M. Valuing pharmaceutical assets: when to use NPV vs rNPV. www.alacrita.com; 2018
- The pharmaceutical industry in figures, key data 2021 [Internet]. European Federation of Pharmaceutical Industries and Associations (efpia). Available from: https://www.efpia.eu/media/602709/the-pharmaceutical-industry-in-figures-2021.pdf
- The global use of medicine in 2019 and outlook to 2023 forecasts and areas to watch [Internet]. IQVIA Institute for Human Data Science; 2019. Available from: https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/the-global-use-of-medicine-in-2019-and-outlook-to-2023.pdf
- Orphan drug act - relevant excerpts [Internet]. Food and Drug Administration; 2013 [cited 2021 Sept 25]. Available from: https://www.fda.gov/industry/designating-orphan-product-drugs-and-biological-products/orphan-drug-act-relevant-excerpts
- Dowlat HA. The opportunities and challenges of biosimilar orphans. Expert Opin Orphan Drugs. 2016;4:563–566
- Orphan designation: overview [Internet]. European Medicines Agency; Available from: https://www.ema.europa.eu/en/human-regulatory/overview/orphan-designation-overview
- Orphan Drugs in the United States. Rare disease innovation and cost trends through 2019. IQVIA Institute for human data science; 2020
- The prospects for biosimilars of orphan drugs in Europe: current landscape and challenges ahead [Internet]. The IQVIA Institute; 2020. Available from: https://www.iqvia.com/insights/the-iqvia-institute/reports/the-prospects-for-biosimilars-of-orphan-drugs-in-europe
- White paper: the impact of biosimilar competition in Europe [Internet]. IQVIA; 2019. Available from: https://ec.europa.eu/docsroom/documents/38461/attachments/1/translations/en/renditions/native
- Wallace D. Biosimilar interchangeability: a blessing or a curse? [Internet]. 2021 [cited 2021 Sept 24]. Available from: https://generics.pharmaintelligence.informa.com/GB151077/Biosimilar-Interchangeability-A-Blessing-Or-A-Curse
- Guidance document: considerations in demonstrating interchangeability with a reference product [Internet]. U.S. Food and Drug Administration; 2019. Available from: https://www.fda.gov/media/124907/download
- Barbier L, Mbuaki A, Simoens S, et al. Regulatory information and guidance on biosimilars and their use across Europe: a call for strengthened one voice messaging. Front Med. 2022;9. doi:10.3389/fmed.2022.820755.
- FDA approves first interchangeable biosimilar insulin product for treatment of diabetes [Internet]. Food and Drug Administration; 2021. Available from: https://www.fda.gov/news-events/press-announcements/fda-approves-first-interchangeable-biosimilar-insulin-product-treatment-diabetes
- FDA approves cyltezo, the first interchangeable biosimilar to humira [Internet]. Food and Drug Administration; 2021. Available from: https://www.fda.gov/news-events/press-announcements/fda-approves-cyltezo-first-interchangeable-biosimilar-humira
- 42 USC §262(k)(6). Licensure of biological products as biosimilar or interchangeable [Internet]. U.S. Government Publishing Office. Available from: https://www.govinfo.gov/content/pkg/USCODE-2016-title42/pdf/USCODE-2016-title42-chap6A-subchapII-partF-subpart1-sec262.pdf
- Viatris and Biocon biologics announce launch of interchangeable SEMGLEE® (insulin glargine-yfgn) injection and insulin glargine (insulin glargine-yfgn) injection, press release [Internet]. Viatris Inc; 2021. Available from: https://newsroom.viatris.com/2021-11-16-Viatris-and-Biocon-Biologics-Announce-Launch-of-Interchangeable-SEMGLEE-R-insulin-glargine-yfgn-Injection-and-Insulin-Glargine-insulin-glargine-yfgn-Injection#:~:text=Viatris%20and%20Biocon%20Biologics%20Announce%20Injection%20%2D%20Nov%2016%2C%202021
- Kansteiner F. Viatris launched 2 versions of its interchangeable insulin biosimilar. Why? [Internet]. Fierce Pharma; 2021. Available from: https://www.fiercepharma.com/pharma/viatris-launches-two-versions-its-interchangeable-biosimilar-semglee-bid-to-tackle-pricing
- Fein A. Why PBMs and payers are embracing insulin biosimilars with higher prices - and what that means for humira [Internet]. Drug Channels Institute; 2021. Available from: https://www.drugchannels.net/2021/11/why-pbms-and-payers-are-embracing.html
- Annual report (Form 20-F) for year 2020, Novartis AG [Internet]. 2021. Available from: https://www.sec.gov/Archives/edgar/data/0001114448/000137036821000006/a21012620f.html
- Annual report (Form 20-F) for year 2020, Sanofi [Internet]. United States Securities and Exchange Commission; 2021. Available from: https://www.sec.gov/edgar/browse/?CIK=1121404&owner=exclude
- Annual report for year 2020, GlaxoSmithKline (GSK) [Internet]. GlaxoSmithKline (GSK); Available from: https://www.gsk.com/media/6662/annual-report-2020.pdf