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Insulin insulated: barriers to competition and affordability in the United States insulin market
Open accessAbstract
Insulin prices in the United States are skyrocketing. In addition to several challenges common to high-priced prescription drugs, insulin faces several unique legal, regulatory, and practical challenges to increasing access and affordability. Despite the fact that insulin was developed almost 100 years ago, the insulin market is dominated by only three companies and there continue to be no biosimilar competitors in the United States. Unlike many high-priced prescription drugs, insulin has been insulated from competition for years. This article examines the barriers to competition in the insulin market, considering the challenges surrounding regulatory approval, interchangeability, trade secrets, and anticompetitive behavior. Further, this article discusses the potential and limitations of various legislative proposals to address access to insulin. In doing so, this article attempts to explain why there is such limited competition in the insulin market and identifies issues specific to the insulin market for lawmakers to consider in developing proposals to address access to affordable insulin in the United States.
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“Currently, GLP1-RAs are manufactured by three main providers, and this oligopoly likely contributes to the elevated costs, as seen with other pharmaceutical agents.107”
From The societal implications of using glucagon-like peptide-1 receptor agonists for the treatment of obesity (2025) · cites this paper as [107]
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“Currently, GLP1-RAs are manufactured by three main providers, and this oligopoly likely contributes to the elevated costs, as seen with other pharmaceutical agents.107”
From The societal implications of using glucagon-like peptide-1 receptor agonists for the treatment of obesity (2025) · cites this paper as [107]
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Yuan, J., Li, M., Jiang, X., & Lu, K. (2024) · BMJ Global Health · doi:10.1136/bmjgh-2023-014489 · Cited by 18
Scragg, J., Koutoukidis, D. A., Dirksen, C., Heitmann, B. L., & Jebb, S. A. (2025) · Med · doi:10.1016/j.medj.2025.100805 · Cited by 16
Santos, D. (2023) · Environmental Innovation and Societal Transitions · doi:10.1016/j.eist.2023.100783 · Cited by 12
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Kusior, A., Mazurków, J., Jeleń, P., Bik, M., Raza, S., Wdowiak, M., Nikiforov, K., & Paczesny, J. (2024) · Langmuir · doi:10.1021/acs.langmuir.4c00642 · Cited by 11
Metadata
- Authors
- Knox, R.
- Affiliations
- Yale University (US)
- Corresponding author
- Knox, Ryan
- ORCID
- Knox, Ryan
- Venue
- Journal of Law and the Biosciences
- Publisher
- Oxford University Press (OUP)
- Published
- 2020-01
- Volume
- 7
- Issue
- 1
- Pages
- lsaa061-lsaa061
- ISSN
- 2053-9711 (ISSN-L)
- PMC
- PMC8249113
- OpenAlex
- W3160235632
- Cited by
- 27
- References
- 0
- Citations by year
- 2026: 5 · 2025: 2 · 2024: 9 · 2023: 7 · 2022: 1 · 2021: 3
- FWCI
- 2.34
- Type
- journal article
- Language
- en
- Open access
- diamond
- doi.org
- Licence
- Locations
- Journal of Law and the Biosciences (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- eScholarship (California Digital Library) (submittedVersion, cc-by-nc-nd)
- Funders
- Eli Lilly and Company
- Novo Nordisk
- Topics
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
- Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Healthcare Policy and Management
- Keywords
- insulin, drug affordability, market competition, biosimilars, trade secrets, anticompetitive practices, regulatory approval, health care legislation, pharmaceutical market
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- The paper
- Knox, R. (2020). Insulin insulated: barriers to competition and affordability in the United States insulin market. Journal of Law and the Biosciences. https://doi.org/10.1093/jlb/lsaa061