Generic immunosuppression in transplantation — benefits and risks

Abstract

Current immunosuppressive drugs have allowedlong-term graft survival by greatly reducing the risk ofits rejection. The use of immunosuppressive drugs isassociated with a significant risk of side-effects and frequent interactions with other medicines and food.Many anti-rejection agents require careful therapeutic drug monitoring. For these reasons most immunosuppressive drugs are classified as medicines with narrow therapeutic index. After the expiration ofa patent protection of original cyclosporine A in 1995most other innovative immunosuppressive drugs have already lost or will lose in the near future a patent protection. That situation allows the introduction of generics that directly compete with original drugs on the market. Although this process may lead to the decrease of the cost of therapy it may also be associated with the substantial risk in case of a conversionfrom the original drug to a generic or from one generic to another. For these reasons experts and scientific societies and regulatory organizations arecurrently working on the regulations that will guarantee that any conversion of an anti-rejection therapy intransplant patient may be done only with a full knowledge of the treating physician. Also the process of the approval of a generic immunosuppressive agent should be more restrictive that for other classes of drugs in order to secure uncompromised transplantand patient survival after a conversion of the therapy.