Insulin Insulated: Barriers to Competition in the United States Insulin Market

Abstract

Insulin is increasingly unaffordable in the United States. Despite the fact that insulin was developed almost one hundred years ago, the insulin market is dominated by only three companies, and there continue to be no biosimilar competitors in the United States. Insulin has been insulated from competition for years. However, insulin is unlike many other high-priced prescription drugs and faces several unique legal, regulatory, and practical challenges to permitting increased competition in the market. This Article examines the barriers to competition in the insulin market, considering the challenges surrounding regulatory approval, pricing, interchangeability, trade secrets, and anti-competitive behavior. In doing so, this Article attempts to explain why there is such limited competition in the insulin market and raises considerations in developing competition-based proposals to address access to affordable insulin in the United States.