Methods, strengths, weaknesses, and limitations of bioequivalence tests with special regard to immunosuppressive drugs

Transpl Int. 2013 Aug;26(8):771-7. doi: 10.1111/tri.12074. Epub 2013 Feb 27.


Within the field of solid organ transplantation, the patents for a number of immunosuppressive drugs have expired in the last few years. Tacrolimus, cyclosporine, and mycophenolate mofetil are now available as generic drugs. In some countries, the market penetration of these generic formulations is as high as 70%, whereas in some other countries, this figure is below 10%. Several professional societies have published position papers on the risks and benefits of generic substitution of immunosuppressive drugs. It often appears that transplant professionals are not fully aware of the requirements for registration of generic drugs. This article describes the registration requirements with a focus on bioequivalence testing, the strengths and weaknesses in this process, and the differences between Europe and the US.

Keywords: bioequivalence; calcineurins antagonists; generics; immunosuppression; mycophenolat mofetil.

Publication types

  • Review

MeSH terms

  • Area Under Curve
  • Drug Approval / legislation & jurisprudence
  • Drug Approval / methods*
  • Drug Monitoring
  • Drug Substitution*
  • Drugs, Generic
  • Europe
  • Fasting
  • Healthy Volunteers
  • Humans
  • Immunosuppressive Agents / pharmacokinetics
  • Immunosuppressive Agents / therapeutic use*
  • Therapeutic Equivalency*
  • Transplantation
  • United States
  • United States Food and Drug Administration


  • Drugs, Generic
  • Immunosuppressive Agents