Generic medications for hepatitis C

Liver Int. 2016 Jul;36(7):925-8. doi: 10.1111/liv.13120.


The recent development and approval of expensive but highly effective oral agents against hepatitis C has led to restrictions and access limitations in many countries with limited healthcare budgets. Generic formulations of many of these agents are available at a fraction of the retail price in several countries because of generic licensure agreements. The discounted alternatives are only accessible in developing countries and require manufacturing and distribution regulations to ensure the quality and bioequivalence of the new drug formulations. The continued medication access limitations have driven great interest in the practice of personal drug importation of the generic formulations. This review and debate will address the medical and legal issues involved in the purchase and importation of these medicines.

Keywords: counterfeit; generic; hepatitis C; regulations.

Publication types

  • Review
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antiviral Agents / economics*
  • Antiviral Agents / therapeutic use
  • Canada
  • Commerce / legislation & jurisprudence
  • Counterfeit Drugs
  • Drug Approval
  • Drug and Narcotic Control
  • Drugs, Generic / economics*
  • Drugs, Generic / therapeutic use
  • Fraud
  • Hepatitis C / drug therapy*
  • Humans
  • Quality Control
  • Safety
  • United States
  • United States Food and Drug Administration


  • Antiviral Agents
  • Counterfeit Drugs
  • Drugs, Generic