Perspective

Published on 13 February 2012

Myths, questions, facts about generic drugs in the EU

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…

Author(s): Christoph Baumgärtel, MD, MSc

bioequivalence, drug substitution, generics authorisation, legislation, patent, therapeutic equivalency/outcome

DOI: 10.5639/gabij.2012.0101.009

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Perspective

Published on 13 February 2012

Generic and therapeutic orphans

Abstract:  This commentary discusses the need to develop methods to ensure the availability of non-profitable, off-patent medicines to children and other populations. The history and some of the shortcomings of legislative attempts to provide drug therapy to children are briefly reviewed. Some examples of the inability of the current generics and non-generics pharmaceutical industry as…

Author(s): Professor Philip D Walson, MD

off-patent drugs, orphan, paediatric

DOI: 10.5639/gabij.2012.0101.010

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Perspective

Published on 10 February 2012

Generic clopidogrel–the medicines agency’s perspective

Abstract:  A number of generic products containing clopidogrel as the active substance have been marketed in Austria and the EU for some time. Due to different clopidogrel salt preparations and different indications, doubts arose as to whether the products could be considered as equivalent. The Austrian Federal Office for Safety in Health Care (BASG)/The Austrian Agency for Health and Food Safety…

Author(s): Christoph Baumgärtel, MD, MSc

bioequivalence, clopidogrel, drug substitution, drugs, generics, therapeutic equivalence

DOI: 10.5639/gabij.2012.0102.019

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