Generic immunosuppression in transplantation: current evidence and controversial issues

Expert Rev Clin Immunol. 2015 May;11(5):659-72. doi: 10.1586/1744666X.2015.1026895. Epub 2015 Mar 30.


The overall success of organ transplantation in the 21st century has been predicated, in part, on the use of newer, more potent, and selective immunosuppressive agents. However, the high cost of lifelong immunosuppression represents a financial burden for many patients. In the past 15 years, regulatory agencies in Europe and America have approved several generic immunosuppressants. One concern is whether the conversion between innovator and generic immunosuppressants will prove to be problematic. This manuscript aims to compare and contrast the bioequivalence requirements among regulatory authorities in the USA, Europe, and Canada, evaluate published studies of generic immunosuppressants in transplant recipients, summarize consensus statements made by transplant organizations and discuss how to engage patients in discussion regarding the choice between innovator and generic immunosuppressants.

Keywords: generic; immunosuppressants; immunosuppression; innovator; organ transplant.

Publication types

  • Review

MeSH terms

  • Animals
  • Canada
  • Consensus
  • Cost-Benefit Analysis
  • Drug and Narcotic Control
  • Drugs, Generic / economics
  • Drugs, Generic / pharmacokinetics
  • Drugs, Generic / therapeutic use*
  • Europe
  • Graft Rejection / prevention & control*
  • Humans
  • Immunosuppression Therapy
  • Immunosuppressive Agents / economics
  • Immunosuppressive Agents / pharmacokinetics
  • Immunosuppressive Agents / therapeutic use*
  • Organ Transplantation*
  • Therapeutic Equivalency
  • Therapies, Investigational*
  • United States


  • Drugs, Generic
  • Immunosuppressive Agents