title: Generic antibiotic drugs: is effectiveness guaranteed?
abstract: There are recently published arguments suggesting all generic antibiotic drugs do not present the full reliability needed to claim therapeutic equivalence with branded drugs. The problem is especially crucial for generic intravenous drugs, which do not need any bioequivalence study before they can be marketed. The evaluation of generic antibiotic drug effectiveness yields an important dispersion of results according to antibiotic agents and for the same antibiotic agent all generic drugs are not equivalent. There are differences at all levels: drug components, levels of impurity, pharmacokinetics, pharmacokinetic/pharmacodynamic relationship, in vitro effectiveness, therapeutic effectiveness in experimental models, etc. So that finally, the specifications approved in the initial submission file of a brand name drugs are not always respected by a generic drug. There is also a specific problem of taste and treatment acceptability for pediatric oral antibiotic drugs. Available data on clinical effectiveness is excessively rare. The marketing of a great number of generic drugs of the same specialty is followed by a sometimes very important increase of their use, even in countries where consumption is low. The corollary of this increase in consumption is an increase of resistance, and this is especially true for oral fluoroquinolones. Even if most of this information needs to be verified, it seems necessary to review regulations for marketing authorization of generic antibiotic drugs.
authors.affiliation: Unité de réanimation, Hôtel Dieu, place du Parvis-de-Notre-Dame, Paris cedex 04, France. remy.gauzit@htd.aphp.fr
authors.forename: R
authors.initials: R
authors.lastname: Gauzit
authors.forename: M
authors.initials: M
authors.lastname: Lakdhari
mesh_terms: D000818:Animals; D000900:Anti-Bacterial Agents / Q000493:pharmacokinetics* / Q000592:standards / Q000627:therapeutic use; D001424:Bacterial Infections / Q000188:drug therapy; D002986:Clinical Trials as Topic; D004353:Drug Evaluation, Preclinical; D004352:Drug Resistance, Microbial; D057915:Drug Substitution; D004363:Drug Utilization; D064420:Drug-Related Side Effects and Adverse Reactions; D016568:Drugs, Generic / Q000493:pharmacokinetics* / Q000592:standards / Q000627:therapeutic use; D005062:European Union; D006291:Health Policy; D006801:Humans; D040541:Marketing / Q000331:legislation & jurisprudence; D055118:Medication Adherence; D051379:Mice; D008826:Microbial Sensitivity Tests; D013810:Therapeutic Equivalency
chemical_list: D000900:Anti-Bacterial Agents; D016568:Drugs, Generic