Benefits and risks of generic substitution

Generics/Research | Posted 20/05/2011 post-comment0 Post your comment

According to the FDA, each year, Americans save an estimated US$8–10 billion by purchasing generic drugs rather than branded medications. These savings are, of course, the key advantage of generics. However, the very reason for these cost savings—the fact that generic drugs do not have to undergo the large, expensive clinical trials that are required for approval of branded drugs—gives rise to questions about the quality and safety of generics.


A literature search carried out by Polish researchers Dr Lewek and Dr Kardas, including 47 studies (38 of which were randomised controlled trials), yielded little evidence that generic drugs are less safe or less effective than their branded equivalents [1].

Generic drugs are produced under strict standards to guarantee their quality. They typically cost 30–60% less than the branded medicine and have the potential to reduce the price of the branded drugs due to competition.

Patient compliance was also found to be better with generics than branded equivalents, with lower co-payments being given as a key factor.

The authors conclude that for most patients taking most medications, generic substitution is not a problem, and saves the patient money. However, they point out that generic substitution of drugs that have a narrow therapeutic range, e.g. antiepileptic drugs, poses potential problems and must be done with caution. Although the FDA does not agree on this point, stating that switching to a generic does not increase the risk of treatment failure in the case of antiepileptic drugs.

The series of two articles that follow will discuss issues surrounding generic substitution in the US.

Related articles

The benefits of generic substitution

Different routes for generics and brand-name drugs


1. Lewek P, Kardas P. Generic drugs: the benefits and risks of making the switch. J Fam Pract. 2010;59(11):634-40.

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