Insulin prices have risen sharply, despite a century since its introduction. Against this backdrop, companies have discontinued dozens of insulin products. Discontinuation could relate to safety or effectiveness, or to the overwhelming 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 discontinuation, 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.

中文翻译：

---

领先领先：方便患者选择胰岛素产品


尽管胰岛素问世已有一个世纪，但其价格仍大幅上涨。在此背景下，公司已经停产了数十种胰岛素产品。停产可能与安全性或有效性有关，或者与新产品的压倒性优势有关。另一方面，停产可能表明战略行为阻碍竞争并支撑价格。为了检验这些理论，该项目检查了每次胰岛素停药，分析停药对胰岛素负担能力的影响。没有证据表明任何停药的安全性或有效性。相反，数十种可行的产品被从市场上撤下，随后出现了更昂贵的版本，通常临床改进很少或根本没有。例如，带有手机应用程序的胰岛素笔可能具有优势。然而，对于老年患者来说，他们可能会觉得这项技术令人困惑，或者对于预算有限的患者来说，价值主张会动摇。此外，停产会阻碍生物仿制药进入市场，因为如果没有该药物，它们就无法证明生物仿制药的生物仿制药。所有生物仿制药都存在这个问题。如果专利到期的临床有效产品有愿意的买家和愿意的卖家，则应为进入提供便利。本文建议公司在 FDA 批准时存放样品，为以后进入具有临床可行结果的前沿产品奠定基础。