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January 25, 2021

Authorized Generics and Their Evolving Role in Prescription Drug Pricing and Access

Author Affiliations
  • 1Department of Health Policy, Vanderbilt University School of Medicine, Nashville, Tennessee
  • 2Vanderbilt-Ingram Cancer Center, Nashville, Tennessee
  • 3Department of Health Care Policy, Harvard Medical School, Boston, Massachusetts
  • 4Division of General Internal Medicine, Brigham and Women’s Hospital, Boston, Massachusetts
JAMA Intern Med. 2021;181(4):423-424. doi:10.1001/jamainternmed.2020.8450

In recent years, amid public outcry over high prices, several large pharmaceutical companies have launched “authorized generic” versions of their brand-name products at steeply reduced list prices, including for epinephrine injectors (EpiPen), insulin (Humalog and NovoLog), and hepatitis C treatments (Harvoni and Epclusa). In each case, the manufacturers garnered positive media attention1,2 when announcing their authorized generic products and the potential savings for patients, even while their brand-name counterparts remained under patent protection for years to come. These examples raise important questions about the incentives for manufacturers of brand-name medicines to introduce authorized generics and whether their availability benefits consumers. In this Viewpoint, we explain what authorized generics are, describe 3 ways that they are used, and consider whether they improve access to prescription drugs or lower out-of-pocket spending for patients.

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