Myths, questions, facts about generic drugs in the EU
Journal Title: Generics and Biosimilars Initiative Journal - Year 2012, Vol 1, Issue 1
Abstract
Many generic drugs are now being prescribed and the trend is increasing. For example, in Austria, the number of all generics prescriptions has more than doubled from 11% in 2000 to 23% in 2010. However, many myths and questions about generic drugs remain and information may be difficult to come by. It is therefore not surprising, as we have discovered in recent years, that even physicians and pharmacists are not always fully up to date in their understanding of generic drugs. Some of their questions centre on issues such as: are generic drugs really as good as the original; are we really dealing with an adequately tested, high quality medicinal product. Today, generic drugs present an equally well-tolerated and efficacious alternative to established medicinal products, which contain well-known, rigorously tested active ingredients. An established originator product undergoes expensive and protracted development (up to 15 years) with inherently high preclinical and clinical research costs in order to be given market approval. The development of generic drugs, on the other hand, is relatively quick and inexpensive, which allows generic drugs to be sold at a distinctly cheaper price. This is due to the waiving of new preclinical and clinical studies, aside from some bioequivalence studies. Their lower price however should not be equated with ‘cheap quality’. In fact, generic medicines undergo the same strict scrutiny by the European or national medicines authorities as reference products. At AGES PharmMed, the Austrian competent authority for marketing authorisation of human medicinal products, generic drugs are subjected to detailed assessment, during which the safety profile and efficacy data of the active substances, as well as the proof of bioequivalence, are thoroughly examined. This is also the case for all other national competent authorities of the EU and EMA. The Austrian Federal Office for Safety in Healthcare issues a marketing authorisation only if all legal and scientific requirements are fulfilled. This marketing authorisation validates the safety, efficacy, and quality of a generic drug.
Authors and Affiliations
Christoph Baumgärtel
Keywords
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- EP ID EP355199
- DOI 10.5639/gabij.2012.0101.009
- Views 96
- Downloads 0
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