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Benefits and risks of generic substitution

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.

Savings due to generic substitution in South Africa

A retrospective analysis of medical claims for antidepressants during 2004–2006 in South Africa calculated potential savings of 9.3% of the actual antidepressant cost over the study period.

Compliance with generic drug use among Pakistani immigrants

Patients using antihypertensives, antidiabetics or cholesterol-lowering drugs were interviewed using a questionnaire in the study which investigated the perceptions of generic substitution among Pakistani immigrants in Oslo, Norway, and how this affected compliance with their long-term drug use and may be affected by confusion of generic drugs with counterfeit drugs [1].

The benefits of generic substitution

Recent research carried out by Drs Lewek and Kardas, showed that generic drugs are equally as safe and effective as their brand-name equivalents. Patient compliance and cost were also found to be better with generics compared to brand-name drugs.

Different routes for generics and brand-name drugs

Comparison of the route to market generics and brand-name drugs was discussed by Dr Lewek and Dr Kardas in their recent research paper on the benefits and risks of generic substitution.

The status of generic substitution in South Africa

In South Africa only around 13% of the population live in what we would call ‘first world’ conditions. More than half the population (around 48 million people) live in developing world conditions according to researchers from the School of Pharmacy at the North-West University, South Africa.

Generic substitution generates savings in South Africa

Savings of 9.3% over the 3-year study period could have been made with generic substitution of antidepressants according to research carried out by the School of Pharmacy at the North-West University, South Africa.

Generic substitution rates in South Africa

Research carried out by the School of Pharmacy at the North-West University, South Africa, has shown that generic substitution rates for antidepressants increased between 2004 and 2006. Meanwhile antidepressant use decreased over the same period while the average cost decreased in 2005, but increased again in 2006.

Bioequivalence of generic cyclosporine

A clinical trial in allogeneic stem cell transplant (ASCT) recipients found that generic and branded cyclosporine could be considered interchangeable.

Value-based pricing – the concept

The concept of value-based pricing (VBP) is outlined. A key purpose of the VBP system is to assess over time whether the drug has achieved its intended goal and justified its cost.