Home > School of Law > Law School Journals > ILJ > Vol. 26 > Iss. 2 (2025)
San Diego International Law Journal
Document Type
Comment
Abstract
The high cost of insulin in the United States is driven by restrictive patent protections, trade secret barriers, regulatory inefficiencies, and anticompetitive practices that limit biosimilar competition. While Canada and Mexico have adopted policies that facilitate market entry and government price negotiations, the United States remains constrained by a regulatory framework that prioritizes exclusivity over affordability. Incremental reforms—such as limiting patent extensions, expediting biosimilar approval, increasing pricing transparency, and strengthening antitrust enforcement —could significantly lower costs and expand access. Previous legislative efforts, including the Inflation Reduction Act, have taken steps toward reform, but broader regulatory restructuring is necessary to ensure meaningful and lasting change. Addressing these systemic barriers is essential to fostering competition, reducing patient costs, and making insulin a truly accessible, life-saving medication.
Recommended Citation
Chloe Mietzel,
Breaking the Vial: Leveraging North American Regulatory Models and Market Practices to Reform Insulin Pricing in the United States,
26
San Diego Int'l L.J.
287
(2025)
Available at:
https://digital.sandiego.edu/ilj/vol26/iss2/5
