[Generic drugs in psychopharmacology: pros and cons].
Legislation to facilitate process for generic products has been enacted and generic drugs have entered the market soon after the patent for the brand-name agent have expired. In every instance, the rationale has been economic since it is generally assumed that the copies are not only therapeutically equivalent but also a great deal less expensive than the original. Sometimes this may be so. In this short review several comments are made in order to establish the variables that may influence bioequivalence between the brand-name drug and its generics. Among them emphasis is given to the particle sizes, pharmaceutical supply, choice of the right excipient, in order to avoid possible interactions with the drug, ingredient quality and purity, etc. All these variables must be carefully controlled. Even so a patient who is changed from a trade name product to a generic drug (or vice versa) may respond a little differently, which is important in Psychopharmacology. Two or more products should be considered biologically equivalent only when it can demonstrated that they fulfil three conditions: that they have the same pharmaceutical properties; that they are equally effective in therapeutic use and that they are tolerated equally by patients being treated for the indicated uses. Regulatory agencies could require subsequent versions of an original therapeutic product the type of data regarding pharmacology, toxicology and chemical assessment that was mandatory for the introduction of the original.
Cuenca
E
E
Departamento de Farmacología, Facultad de Medicina, Alcalá de Henares, Madrid, 28871, España. dep441@alcala.es
Zaragozá
F
F
D016568:Drugs, Generic / Q000592:standards; D006801:Humans; D011600:Psychopharmacology / Q000592:standards
D016568:Drugs, Generic