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The clinical equivalence of brand-name beta-blockers and their generic counterparts

The healthcare systems of the world are all under pressure to reduce costs and using generic substitution for the initially prescribed, more expensive equivalents is an obvious area to investigate. However, as a report reiterated in 2010, treatment decisions should not be based on economic grounds alone, for this would not be in the patient's best interest and would therefore be unethical. What is needed is an opinion based on the evidence available regarding therapeutic equivalence [1].

The rise in power of generic drugs

With shrinking pipelines, the impending expiration of many drug patents, and the global economic downturn experienced in the last two years causing prescription payers to face budget cuts, generic drugs are becoming an increasingly large player in the economics of the global pharmaceutical industry.

Generic or brand-name drugs for cardiovascular disease? Does the evidence match current opinion?

Cardiovascular drugs constitute a large proportion of outpatient prescription drug spending.

Are generic diuretics clinically equivalent to their brand-name counterparts for the management of cardiovascular disease?

Prescription costs are rising, mainly due to brand-name drugs recouping their investment during the period of patent protection and market exclusivity. For this reason, many payers and prescribers encourage use of the cheaper generic versions [1]. This has been found to have another positive consequence, namely the increased accessibility to prescription treatments and an increased compliance with drug regimens, particularly in the case of chronic conditions [2, 3].

The clinical equivalence of generic and brand-name calcium channel blockers

Companies seeking to launch a generic drug are required to submit a dossier to authorities, which does not contain the results of extensive preclinical and clinical testing demonstrating safety and efficacy in the target population, as is the case with novel drugs, but only limited data and evidence demonstrating the fundamental premise that the generic is bioequivalent to its brand-name counterpart.

The therapeutic equivalence of antiplatelet agents, ACE-inhibitors, statins and alpha-blockers

The potential changes in pharmacy formulary policy, due to the availability of generic versions of cardiovascular drugs, should be based on as much evidence as possible.

The therapeutic equivalence of brand-name and generic narrow therapeutic index (NTI) cardiovascular drugs

There are many physicians and patients who have concerns that the bioequivalent generics may not have an equivalent nature in terms of their clinical effect and benefit. In the realm of cardiovascular disease, this can include such parameters as heart rate, blood pressure and laboratory measurements.

International trends in generics: the EU

Few studies have conducted an international price comparison of generic medicines as it is hard to access comparable data. A 2007 study by Prof. Dr. Steven Simoens examined national pricing policies in some EU countries and related them to generics prices (see Table 1).

Medicines pricing policies in Europe: a review

The OECD countries spent 4.6% more per capita per year on pharmaceuticals from 1995 to 2005 although the annual average economic growth was only 2.2% during the same period [1].

The generic drug wars: deeply discounted medication

Fierce competition among major pharmacy chains in the US, such as CVS, Walgreens and Walmart, has led to a generic prescription pricing war with unclear public health implications.