What lessons can be learned from the launch of generic clopidogrel?
Journal Title: Generics and Biosimilars Initiative Journal - Year 2012, Vol 1, Issue 2
Abstract
Introduction and study objectives: Resource pressures will continue to grow. Consequently, health authorities and health insurance agencies need to take full advantage of the availability of generics in order to continue funding comprehensive health care particularly in Europe. Generic clopidogrel provides such an opportunity in view of appreciable worldwide sales of the originator. However, early formulations contained different salts and only limited indications. Consequently, there is a need to assess responses by the authorities to the early availability of generic clopidogrel including potential reasons preventing them from taking full advantage of the situation. In addition, it is necessary to determine the extent of initial price reductions obtained in practice to guide future activities. Methods: Feedback from health authorities and health insurance personnel involved with the reforms surrounding generic clopidogrel was principally used to assess authority responses as there is limited information in the public domain. Abu Dhabi has been included as a representative of the Middle East since it has introduced compulsory international non-proprietary name (INN) prescribing except for limited situations. Generic clopidogrel is not one of these – providing direction to other health authorities alongside, e.g. Lithuania. Australia has also been included in view of the high court ruling in favour of generic clopidogrel. Results: Authorities from across Australia, Europe and the Middle East typically adopted a pragmatic approach to the availability of generic clopidogrel to enhance its prescribing and dispensing once approved by regulatory agencies such as EMA. This included guidance to enhance its utilisation such as academic publications, co-payment incentives and compulsory INN prescribing. However, this was not always possible with challenges to the availability of generics in some countries. Again, there was appreciable variation in the initial price reductions for generic clopidogrel versus the originator. Conclusion: Authorities can take full advantage of the early availability of generics despite different formulations and indications. Pharmaceutical companies need to accept this in order to help fund new premium price products as resource pressures grow.
Authors and Affiliations
Christoph Baumgärtel, Brian Godman, Rickard E Malmstrom, Morten Andersen, Mohammed Abuelkhair, Shajahan Abdu, Marion Bennie, Iain Bishop, Thomas Burkhardt, Sahar Fahmy, Jurij Furst, Kristina Garuoliene, Harald Herholz, Marija Kalaba, Hanna Koskinen, Ott Laius, Julie Lonsdale, Kamila Malinowska, Anne M Ringerud, Ulrich Schwabe, Catherine Sermet, Peter Skiold, Ines Teixeira, Menno van Woerkom, Agnes Vitry, Luka Vončina, Corrine Zara, Lars L Gustafsson
Keywords
Related Articles
- EP ID EP355152
- DOI 10.5639/gabij.2012.0102.016
- Views 98
- Downloads 0
Role of hospital clinical pharmacist in transplantation, and generic immunosuppressive therapies
The pharmacist is an important patient advocate in the transplant multidisciplinary team and can support patients in their medication taking to improve medication adherence. Medicine optimization and patient information...
The biosimilar name debate: what’s at stake for public health
As the number of innovator biologics and biosimilars increases worldwide, a growing debate has focused on how these products should be named. The simple concept of a name can have significant impact on prescribing, dispe...
Equal protection under the law: Children and the Best Pharmaceuticals for Children Act
Four changes to the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act will markedly improve these programmes: expanded attention paid to neonatal studies, support for the off -patent programme,...
Safety and toxicity of biosimilars—EU versus US regulation
Background: As patents for biological drugs begin to expire, the need for scientific guidance on biosimilar drugs grows increasingly important. The European Medicines Agency provided the first guidelines to cover the app...
Innovator companies should focus on innovations
Despite biopharmaceuticals having an enormous potential value for our health, they have also become a serious threat to our healthcare systems.