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Report of the American Society of Transplantation Conference on Immunosuppressive Drugs and the Use of Generic Immunosuppressants
Author(s) -
Alloway Rita R.,
Isaacs Ross,
Lake Kathleen,
Hoyer Peter,
First Roy,
Helderman Harold,
Bunnapradist Suphamai,
Leichtman Alan,
Bennett M. William,
Tejani Amir,
Takemoto Steven K.
Publication year - 2003
Publication title -
american journal of transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.89
H-Index - 188
eISSN - 1600-6143
pISSN - 1600-6135
DOI - 10.1046/j.1600-6143.2003.00212.x
Subject(s) - medicine , innovator , bioequivalence , immunosuppression , transplantation , intensive care medicine , immunology , pharmacology , surgery , pharmacokinetics , intellectual property , computer science , operating system
Considerable economic and health‐related costs are associated with the life‐long maintenance immunosuppressive therapy required to prevent transplant rejection. Generic medications have the potential of providing equivalent therapeutic efficacy at a lower economic cost. In 2001, the American Society of Transplantation invited experts to review the data and issues associated with the approval and use of generic immunosuppressants. A summary of that meeting is reported here . The generic medication approval process has been in effect for more than 30 years. All marketed generic cyclosporin formulations have met FDA criteria demonstrating bioequivalence in healthy subjects, and some were also tested in transplant recipients . Most participants agreed that generic narrow therapeutic index immunosuppressive agents provide adequate de novo immunosuppression in low‐risk transplant recipients. However, some participants expressed concern regarding the currently unquantified risk that may be associated with switching immunosuppressive agents under uncontrolled circumstances. There was broad agreement among the participants that generic medications should be clearly labeled and distinguishable from innovator drugs, and that patients should be educated to inform their physicians of any switch to or among generic alternatives. There was also strong support in favor of requiring studies to demonstrate bioequivalence in potentially at‐risk patient populations, specifically African‐Americans and pediatric patients.