It is my pleasure to introduce the second edition of GaBI Journalwhich contains a number of interesting articles. Professors Benjamin and Kearns present a review of advances in paediatric drug development and labelling, see pages 54–55. This follows on my prior comments about how generics and biosimilars may fail to meet the needs of children .
Other original articles discuss a wide range of topics including the lessons learned from the launch of generic clopidogrel (by Dr Christoph Baumgartel et al., pages 58–68); how generic drug use has improved prescribing practices in a number of countries (by Dr Brian Godman et al., pages 69–83); the role of public–private partnerships in promoting access to generics and biosimilars (by Timothy Mackey and Professor Bryan Liang, pages 84–88); a medicine agency’s view of some of the lessons learned from the introduction of the generic ‘blockbuster’ drug clopidogrel (by Dr Christoph Baumgartel, pages 89–91); an overview on the impact of pharmaceutical pricing and reimbursement policies on generics uptake in 29 European countries (by Dr Sabine Vogler, pages 93–100); and a brief overview of the successful Dutch generics substitution system (by Dr Leonora Grandia and Professor Arnold G Vulto, pages 102–103).
There are also three articles prepared by our editors. One reviews the regulatory issues concerning EU rules on pharmacovigilance (pages 56–57), another one discusses how EMA risk management plans (page 104) could increase consumer conﬁdence in generics or biosimilars and the ﬁnal article discusses how biosimilars could provide at least a partial solution to the rapidly increasing cost of effective but extremely expensive oncology treatments (page 104).
The publisher and I hope you will enjoy this issue, that you will provide feedback, positive or negative, on the journal or any of these articles. We also hope you will both submit manuscripts and encourage others to do the same.
1. Walson P. Generic and therapeutic orphans. Generics and Biosimilars Initiative Journal (GaBI Journal). 2012;1(1):39-41. doi:10.5639/gabij.2012.0101.010
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