Publication Date

2023

Abstract

Insulin prices have risen sharply, despite a century since its introduction. Against this backdrop, companies have discontinued dozens of insulin prod- ucts. Discontinuation could relate to safety or effectiveness, or to the over- whelming benefits of newer products. On the other hand, discontinuation could suggest strategic behavior hampering competition and supporting prices. To test these theories, this project examined every insulin discontin- uation, analyzing the role discontinuations play in insulin affordability. No evidence emerged of any discontinuation for safety or effectiveness. Rather, dozens of viable products were removed from the market, followed by more expensive versions, often with little or no clinical improvement. Insulin pens with a phone app may provide advantages, for example. However, for older patients, who may find the technology confusing, or for patients with budget constraints, the value proposition falters. Moreover, discontinuation blocks biosimilars from market entry because they cannot demonstrate biosimilarity without the drug. The problem exists for all biosimilars. If there are willing buyers and willing sellers of clinically effective products that are off-patent, entry should be facilitated. This article suggests a requirement that companies deposit samples at the time of FDA approval, laying the groundwork for later entry of trailing-edge products with clinically viable outcomes.

Document Type

Article

Publication Title

Journal of Law and the Biosciences

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