[HTML][HTML] What lessons can be learned from the launch of generic clopidogrel?

C Baumgartel, B Godman, R Malmstrom, M Andersen… - 2012 - gabi-journal.net
C Baumgartel, B Godman, R Malmstrom, M Andersen, M Abuelkhair, S Abdu, M Bennie…
2012gabi-journal.net
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, eg Lithuania …
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, eg 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.
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