Generic drug substitution in transplantation: Examples from the epic of cyclosporine development

Generic medications have the potential of reducing post-transplant costs in a manner similar to the cost benefits of generics being realized in other therapeutic areas. It is estimated that the use of available generic drugs in a typical immunosuppressive regimen could reduce annual cost to Medicare by almost $2,000 per patient. It was our goal to critically review cyclosporine bioequivalence issues in light of new bioequivalence clinical data that have become available from the development of generic cyclosporine formulations. Under the current criteria of the US. Food and Drug Administration (FDA), the transplant community can be assured that generics, including immunosuppressive medications, are bioequivalent to the innovator drugs and are, therefore, safe and effective. With the innovation of generic immunosuppressants, the transplant community should develop bioequivalence educational resources for physicians and patients. Education, understanding, and use of generic transplant medications will engender continued cost- related benefits in the field of transplantation.