Unlike in Europe, US healthcare systems and payers are still awaiting significant savings related to biosimilar utilization. Costs related to biologic use continue to rise at double-digit rates, and biosimilars are seen as a major tool to control costs and increase access to biologic drugs. However, one 2018 report indicated that US$3.2 billion (only 3%) of biologic spending is subject to competition from biosimilar products. Although the European Medicines Agency did a great deal of pioneering work in biosimilar regulation, the US Food and Drug Administration is moving at approximately the same pace as the European Medicines Agency, based on the number of approvals at the same time after implementation of its regulatory pathway. Several unique factors in the USA have conspired to limit biosimilar access (e.g. delayed regulatory policies, extended patent litigation activities, federal reimbursement policies, the widespread use of rebate contracting, and limited competition). The US Federal Government is taking the initiative in an attempt to address these factors, and speed both biosimilar development and patient access. To date, the most significant cost savings in the US system associated with the introduction of biosimilars may be their ability to halt price increases of the reference product. The complexity of the healthcare delivery system, and how it is financed, will remain challenging to payers, manufacturers, health providers and patients as they seek ways to manage health expenditure growth.
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Mestre-Ferrandiz J, Towse A, Berdud M. Biosimilars: how can payers get long-term savings? PharmacoEconomics. 2016;34:609–16.
Aladul MI, Fitzpatrick RW, Chapman SR. The effect of new biosimilars in rheumatology and gastroenterology specialities on UK healthcare budgets: results of a budget impact analysis. Res Soc Admin Pharm. 2018. https://doi.org/10.1016/j.sapharm.2018.05.009.
Moorkens E, Vulto AG, Huys I, et al. Policies for biosimilar uptake in Europe: an overview. PLoS One. 2017;12(12):e0190147. https://doi.org/10.1371/journal.pone.0190147. (Accessed July 18, 2018).
Dylst P, Vulto A, Simoens S. Barriers to the uptake of biosimilars and possible solutions: a Belgian case study. Pharmacoeconomics. 2014;32:681–91.
Bocquet F, Loubière A, Fusier I, Cordonnier AL, Paubel P. competition between biosimilars and patented biologics: learning from European and Japanese experience. Pharmacoeconomics. 2016;34:1173–86.
Mehr SR, Brook RA. Factors influencing the economics of biosimilars in the US. J Med Econ. 2017;20:1268–71.
Drug Trend Report. Express Scripts Inc. 2018. http://lab.express-scripts.com/lab/drug-trend-report/2017-dtr. Accessed 18 July 2018.
Islam I. Rising cost of drugs: where do we go from here? Health affairs blog. 2015. http://healthaffairs.org/blog/2015/08/31/rising-cost-of-drugs-where-do-we-go-from-here/. Accessed 22 July 2018.
Aitken M, Kleinrock M. Medicines use and spending in the U.S.: a review of 2016 and outlook to 2021. Parsippany, NJ: IQVIA Institute for Human Data Science; 2017. PB.0003-1-11.2017. https://www.iqvia.com/institute/reports/medicines-use-and-spending-in-the-us-a-review-of-2016. Accessed 4 Sept 2018.
Mehr S. What will cost savings on 2023 adalimumab biosimilars really be worth? Biosimilars Reviews & Reports. 2018. https://biosimilarsrr.com/2018/02/05/what-will-cost-savings-on-2023-adalimumab-biosimilars-really-be-worth/. Accessed 18 July 2018.
Biosimilars approved in Europe. Generics and biosimilars initiative. http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe. Accessed 5 Dec 2018.
The Patient Protection and Affordable Care Act. Public law 111–148. 2010. https://www.congress.gov/111/plaws/publ148/PLAW-111publ148.pdf. Accessed 28 July 2018.
Mehr S. Biosimilar approval status. Biosimilars Review & Report. 2018. https://biosimilarsrr.com/us-biosimilar-filings/. Accessed 5 Dec 2018.
Pfizer completes acquisition of Hospira (press release). Pfizer Inc. 2015. https://www.pfizer.com/news/press-release/press-release-detail/pfizer_completes_acquisition_of_hospira. Accessed 18 July 2018.
Sandoz decides not to pursue US biosimilar rituximab; will focus on robust biosimilar portfolio for unmet access and sustainability (press release). Novartis. 2018. https://www.novartis.com/news/media-releases/sandoz-decides-not-pursue-us-biosimilar-rituximab-will-focus-robust-biosimilar-portfolio-unmet-access-and-sustainability-needs. Accessed 3 Dec 2018.
Biosimilar action plan: balancing innovation and competition. Food and Drug Administration. 2018. https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM613761.pdf. Accessed 29 July 2018.
Goldsmith D, Dellanna F, Schiestl M, et al. Epoetin biosimilars in the treatment of renal anemia: what have we learned from a decade of European experience? Clin Drug Investig. 2018;38:481–90.
Ingrasciotta Y, Cutroneo PM, Marciano I, et al. Safety of biologics, including biosimilars: perspectives on current status and future direction. Drug Saf. 2018;41(11):1013–22. https://doi.org/10.1007/s40264-018-0684-9.
Cohen J. What’s holding back market uptake of biosimilars? Forbes. 2018. https://www.forbes.com/sites/joshuacohen/2018/06/20/whats-holding-back-market-uptake-of-biosimilars/. Accessed 4 Aug 2018.
Davio K. Pfizer execs underscore the need for a level playing field for biosimilars. Center for Biosimilars. 2018. https://www.centerforbiosimilars.com/news/pfizer-execs-underscore-the-need-for-a-level-playing-field-for-biosimilars. Accessed 18 July 2018.
Pfizer goes to court to allow competition for biologics and expand options for patients (press release). Pfizer. 2017. https://www.businesswire.com/news/home/20170920005755/en/. Accessed 22 July 2018.
Walgreen Co and The Kroger Co v. Johnson & Johnson and Janssen Biotech, Inc. US District Court Eastern District of Pennsylvania. Civil action no. 2:17-cv-4326-JCJ. 2018.
Rémuzat C, Kapuśniak 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. https://doi.org/10.1080/20016689.2017.1307315.
Bocquet F, Paubel P, Fusier I, et al. Biosimilar granulocyte-stimulating factor uptakes in the EU-5 markets: a descriptive analysis. Appl Health Econ Health Policy. 2014;12:315–26.
The Impact of Biosimilar Competition in Europe. IMSQuintiles. 2017. https://www.medicinesforeurope.com/wp-content/uploads/2017/05/IMS-Biosimilar-2017_V9.pdf. Accessed 18 July 2018.
Aronson JK, Goldacre B, Ferner RE. Prescribing biosimilars (editorial). BMJ. 2018;362:k3141.
Aitken M. Delivering on the potential of biosimilar medicines: the role of functioning competitive markets. IMS Institute for Healthcare Informatics. 2016. http://www.imshealth.com/files/web/IMSH%20Institute/Healthcare%20Briefs/Documents/IMS_Institute_Biosimilar_Brief_March_2016.pdf. Accessed 18 July 2018.
Commissioning framework for biological medicines (including biosimilar medicines). National Health Service, National Medical Directorate. 2017. https://www.england.nhs.uk/publication/commissioning-framework-for-biological-medicines/. Accessed 28 July 2018.
Considerations in demonstrating interchangeability with a reference product guidance for industry. Food and Drug Administration. 2017. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM537135.pdf. Accessed 18 July 2018.
Biosimilars and interchangeable drug products legislation and laws. Academy of Managed Care Pharmacy. 2018. http://www.amcp.org/WorkArea/DownloadAsset.aspx?id=22789. Accessed 4 Aug 2018.
Biosimilars in the EU—information guide for healthcare professionals. European Commission. 2017. http://ec.europa.eu/DocsRoom/documents/2294. Accessed 18 July 2018.
Removal of safe harbor protection for rebates to plans or PBMs involving prescription pharmaceuticals and creation of new safe harbor protection. Office of Management and Budget. 2018. https://www.reginfo.gov/public/do/eoDetails?rrid=128288. Accessed 4 Aug 2018.
Gottlieb S. Capturing the benefits of competition for patients. Remarks to a meeting of America’s Health Insurance Plans, Washington, DC. 2018. https://www.fda.gov/NewsEvents/Speeches/ucm599833.htm. Accessed 18 July 2018.
Cubanski J. Summary of recent and proposed changes to Medicare prescription drug coverage and reimbursement. Kaiser Family Foundation. 2018. https://www.kff.org/medicare/issue-brief/summary-of-recent-and-proposed-changes-to-medicare-prescription-drug-coverage-and-reimbursement/. Accessed 8 Aug 2018.
Part B biosimilar biologic product payment and required modifiers. Centers for Medicare and Medicaid Services. 2018. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/Part-B-Biosimilar-Biological-Product-Payment.html. Accessed 8 Aug 2018.
Scientific considerations in demonstrating biosimilarity to a reference product. Food and Drug Administration 2015. https://www.fda.gov/downloads/drugs/guidances/ucm291128.pdf. Accessed 18 July 2018.
Brook RA, Carlisle JA, Smeeding JE. Management of specialty drugs, specialty pharmacies and biosimilars in the United States. J Manag Care Spec Pharm. 2018;24(4-a):s101.
Cohen HP, Blauvelt A, Rifkin RM, et al. Switching reference medicines to biosimilars: a systematic literature review of clinical outcomes. Drugs. 2018;78:463–78.
Blauvelt A, Lacour JP, Fowler JF Jr, et al. Phase III randomized study of the proposed adalimumab biosimilar GP2017 in psoriasis: impact of multiple switches. Br J Dermatol. 2018. https://doi.org/10.1111/bjd.16890 (Epub ahead of print).
NEW—The VOLTAIRE-X trial looks at the effect of switching between Humira and BI 695501 in patients with plaque psoriasis. ClinicalTrials.gov. 2018. https://www.clinicaltrials.gov/ct2/show/NCT03210259?term=Cyltezo&rank=1.. Accessed 3 Dec 2018.
Jørgenson KK, Olsen IC, Goll GL, et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Lancet. 2017;389:2304–16.
Aitken M (ed). Medicines use and spending in the U.S. A review of 2016 and outlook to 2021. QuintilesIMS Institute. 2017. http://www.imshealth.com/en/thought-leadership/quintilesims-institute/reports. Accessed 18 July 2018.
Miller S. The $250 billion potential of biosimilars. Express scripts. 2013. http://lab.express-scripts.com/lab/insights/industry-updates/the-$250-billion-potential-of-biosimilars. Accessed 18 July 2018.
Manolis CH, Rajasenan K, Harwin W, et al. Biosimilars: opportunities to promote optimization through payer and provider collaboration. J Manag Care Pharm. 2016;22(9 Suppl):S3–9.
Danese S, Fiorino G, Michetti P. Changes in biosimilar knowledge among European Crohn’s Colitis Organization [ECCO] members: an updated survey. J Crohns Colitis. 2016;10:1362–5.
Cohen H, Beydoun D, Chien D, et al. Awareness, knowledge and perceptions of biosimilars among specialty physicians. Adv Ther. 2017;33:2160–72.
Frank RG. Friction in the path to use of biosimilar drugs. N Engl J Med. 2018;378:791–3.
Grewal S, Ramsey S, Balu S, Carlson JJ. Cost-savings for biosimilars in the United States: a theoretical framework and budget impact case study application using filgrastim. Expert Rev Pharmacoecon Outcomes Res. 2018;18:447–54.
Standard list of formulary removals and updates. CVS Health. 2017. http://investors.cvshealth.com/~/media/Files/C/CVS-IR-v3/documents/02-aug-2016/2017-standard-formulary-list-of-removals-and-updates.pdf. Accessed 29 Dec 2018.
Dangi-Garmilla S. UnitedHealth’s 2017 formulary to support generic and biosimilar drugs. AJMC.com. 2016. http://www.ajmc.com/newsroom/unitedhealths-2017-formulary-to-supportgeneric-and-biosimilar-drugs. Accessed 24 July 2018.
VA National Formulary Changes. 2017. https://www.pbm.va.gov/nationalformulary.asp. Accessed 24 July 2018.
Pollack A. Makers of Humira and Enbrel using new drug patents to delay generic versions. New York Times. 2016. https://www.nytimes.com/2016/07/16/business/makers-of-humira-and-enbrel-using-new-drug-patents-to-delay-generic-versions.html?_r=0. Accessed 10 June 2017. Accessed July 28, 2018.
Momenta signs licensing deal with Abbvie. Did it have a choice? Biosimilars Reviews & Reports. 2018. https://biosimilarsrr.com/2018/11/08/momenta-signs-fourth-licensing-deal-with-abbvie/. Accessed 5 Dec 2018.
Q1 2018 Amgen Earnings Conference Call. 2018. http://investors.amgen.com/phoenix.zhtml?c=61656&p=irol-eventDetails&EventId=5269610. Accessed 8 Aug 2018.
This paper was not funded by any third party.
Conflict of interest
Mr. Mehr disclosed that he has consulted for Boehringer Ingelheim and Sandoz, and he owns stock in Coherus Biosciences. Mr. Brook disclosed that he has no relevant business to disclose.
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Mehr, S.R., Brook, R.A. Biosimilars in the USA: Will New Efforts to Spur Approvals and Access Spur Uptake and Cost Savings?. Pharm Med 33, 1–8 (2019). https://doi.org/10.1007/s40290-018-00262-z