GENERICS IN TRANSPLANTATION, AND THE INTERNATIONAL RULES AND REGULATIONS ON THEIR USEMA

Abstract

By definition a product identified by its official chemical name rather than an advertised brand name is called a generic. If a drug exerts its pharmacological effects at the same site, and has the same potency, dosage form and bioavailability as a brand name reference‐listed drug (RLD), it is consider as a generic. However, inactive ingredients can differ between a brand name and a generic. Generics gained ground in the drug market through the regulations of the FDA; they currently account for more than 42% of the total prescription rate in the USA. These regulations include the abbreviated new drug application (ANDA) for the registration process and drug substitution at the pharmacy level without patient or physician consent. This coupled with a keen interest of third‐party payers and the health authorities to reduce the high transplant health budget (>2 billion US$) made it necessary to introduce generics into the field of transplantation. Using the above‐mentioned definition we can theoretically say that all antilymphocytes produced in the same animal species are generic of each other. Moreover monoclonal antibodies that are directed against the same target and have the same bioavailability are also considered generics of each other. Of all the immunosuppressive drugs that have been introduced into the field of transplantation, none has been as dominant as Cyclosporine. Cyclosporine became and remains the backbone for any immunosuppressive protocol. In 1992, Consupren, the first non‐FDA approved generic to Sandimmun, was introduced. Although Consupren was not bioequivalent to Neoral, the long‐term results in kidney transplantation have been similar for both drugs. The introduction of Consupren resulted in a nearly 40% reduction in the total cost of immunosuppressive therapy. Interestingly, the cost of the brand name drug Neoral was also reduced by 20%. The cost reduction allowed the introduction of the new immunosuppressive agents MMF and Rapamycin. Currently there are five FDA‐approved Cyclosporine generics with a 20% market share in the USA and 0% in Europe. Alternative formulations to both Rapa and MMF should be available soon. These forms are not by definition generics and are considered by the FDA to be new brand names acting on the same site as Cell Cept and Rapaimmune. Their introduction would be a great welcome and would definitely result in cost saving in transplantation.