title: The generics in transplantation and the rules on their use.
abstract: By definition a product identified by its official chemical name rather than an advertised brand name is called a generic. If a drug exert its pharmacological effects at the same site, have the same potency, same dosage form and same bioavailability as a brand name, reference listed drug (RLD), is considered as a generic. However inactive ingredients can differ between brand name and generic. It is through the regulations of the FDA that the generics gained many ground in the drug market, they currently account to more than 42% of the total prescription 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 (over 2 Billion US $) made it a necessity to introduce the generics into the field of transplantation. Using the above mentioned definition we can theoretically say that all anti-lymphocytes, produced in the same animal species, are generic of each. Moreover, monoclonal antibodies that are directed against the same target and have the same bioavailability are also consider generics to 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 still is the backbone for any immunosuppressive protocol. In the year 1992, Consupren, the first, non-FDA approved, generic to Sandimmun was introduced. Although Consupren was not bioequivalent to Neoral, however, long-term results in kidney transplantation have been similar for both drugs. The introduction of Consupren resulted in a near 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 5 FDA approved Cyclosporine generics with a 20% market share in the USA and a mere 0% in Europe. Alternatives formulations to both Rapa and for MMF would be available soon. These forms are not by definition generics and are considered by the FDA to be new brand names act on the same site as Cell Cept and Rapaimmune. Their introduction would be a great welcome and would definitely results in cost saving in transplantation cost. In conclusion, generics efficacy and safety is similar to that of the brand name and their use is cost effective.
authors.affiliation: Rizk Hospital, P.O. Box 11-3288, Beirut, Lebanon. marwan.masrimysalima.com
authors.forename: Marwan
authors.initials: M
authors.lastname: Masri
mesh_terms: D017046:Cost Savings; D016527:Drug Costs; D016568:Drugs, Generic / Q000191:economics / Q000627:therapeutic use*; D006801:Humans; D007166:Immunosuppressive Agents / Q000191:economics / Q000627:therapeutic use; D016377:Organ Transplantation; D017410:Practice Guidelines as Topic; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D016568:Drugs, Generic; D007166:Immunosuppressive Agents