Patent Thickets Delay Biosimilar Access: Humira Case Study Reveals Industry Tactics

References

1. 1.Amin, T., & Malpani, R. (2026, May 26). The innovation trap: How pharma weaponizes a word to extend monopolies. STAT News. https://www.statnews.com/2026/05/26/humira-patents-abbvie-innovation-pharma-monopoly-excerpt/
2. 2.Senate Committee on Finance. (2024). Prescription drug pricing: Examining the practices of pharmaceutical companies. Congressional Hearing Record. https://www.finance.senate.gov/hearings/prescription-drug-pricing
3. 3.House Committee on Oversight and Reform. (2024). Investigation into pharmaceutical patent practices. Congressional Investigation Report. https://oversight.house.gov/investigation/pharmaceutical-patents
4. 4.Winter, G., Smith, G. P., & Arnold, F. H. (2018). Directed evolution of enzymes and binding proteins. Nobel Prize in Chemistry. https://www.nobelprize.org/prizes/chemistry/2018/summary/
5. 5.Hernandez, I., Bott, S. W., Patel, A. S., Wolf, C. G., Hospodar, A. R., Sampathkumar, S., & Shrank, W. H. (2018). Pricing of monoclonal antibody therapies: Higher if used for cancer? American Journal of Managed Care. https://www.ajmc.com/view/pricing-of-monoclonal-antibody-therapies-higher-if-used-for-cancer
6. 6.AbbVie Inc. (2023). Annual Report 2023. SEC Filing 10-K. https://investors.abbvie.com/sec-filings
7. 7.Socal, M. P., Bai, G., & Anderson, G. F. (2019). Favorable formulary placement of branded drugs in Medicare Part D is associated with higher prices. Health Affairs, 38(10), 1652-1660. https://doi.org/10.1377/hlthaff.2018.05071
8. 8.Mulcahy, A. W., Hlavka, J. P., & Case, S. R. (2018). Biosimilar cost savings in the United States: Initial experience and future potential. RAND Corporation. https://www.rand.org/pubs/perspectives/PE264.html
9. 9.Feldman, R., & Frondorf, E. (2017). Drug wars: How big pharma raises prices and keeps generics off the market. Cambridge University Press. https://doi.org/10.1017/9781316717424
10. 10.Kesselheim, A. S., Avorn, J., & Sarpatwari, A. (2016). The high cost of prescription drugs in the United States: Origins and prospects for reform. JAMA, 316(8), 858-871. https://doi.org/10.1001/jama.2016.11237