MAR 26, 2013
The authors of this review article stress the importance of closely monitoring patients using generic drugs, as they are not necessarily therapeutically equivlent to branded drugs.
They reviewed the process of genericization of medications in the U.S. and Europe with a focus on ophthalmic drugs. They examined various studies comparing the safety and efficacy of generic drugs with their branded counterparts, explores the regulatory guidelines of the FDA and the European Medicines Agency (EMA), and discusses the advantages and concerns of so-called "genericization."
They write that the influence of the generic drug industry is rising as more and more brand-name products go off patent. This, in turn, increases the importance of monitoring and studying patient experience with generic drugs.
They note thath while generic drugs are tested for bioequivalence within a certain range compared to innovator drugs, safety and efficacy testing is not required. Therefore, generic drugs are not necessarily therapeutically equivalent to branded drugs. Many studies have found issues, such as decreased efficacy and increased adverse effects, in patients transitioning from branded to generic drugs.
They conclude that FDA and EMA regulations regarding Phase IV monitoring studies may need to be reformed so that generic drugs are required to be therapeutically equivalent in clinical trials to their parent drugs. Until more peer-reviewed, published studies comparing generic drugs to branded drugs are available, clinicians must closely monitor patients after transitioning from branded to generic drugs to ensure patient safety and to monitor any changes in efficacy.