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.
Keywords: biologics; biosimilars; competition; drug pricing; food and drug law; insulin.
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