Sanofi fined for discouraging generic clopidogrel prescriptions

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Sanofi fined for discouraging generic clopidogrel prescriptions

Generics/News | Posted 17/05/2013 0 Post your comment

On 14 May 2013, French drugmaker sanofi-aventis was fined Euros 40.6 million by the French competition authority (L’Autorité de la concurrence) for marketing practices that discouraged sales of generic versions of its blood thinner Plavix (clopidogrel).

The decision comes after Teva Santé, the French division of generics giant Teva Pharmaceutical Industries (Teva), complained back in 2010 that sales representatives for sanofi-aventis were spreading criticism about clopidogrel generics.

The French competition authority states that sanofi-aventis employed ‘a denigration strategy’ against clopidogrel generics. The company implemented a global and structured communication strategy aimed at physicians and pharmacists in order to limit the entry of generics into the market and favour sanofi-aventis’ own products, the originator Plavix and its own generic version, Clopidogrel Winthrop.

Generic drug substitution was prevented at two key stages according to the findings of the French competition authority:

At the prescription stage, by convincing doctors to insert the indication ‘non substitutable’ on prescriptions, so as to limit the substitution of Plavix by a generic medicine.
At the substitution stage itself, by encouraging pharmacists to substitute Plavix by its own generic medicine, Clopidogrel Winthrop, to the detriment of generic drug competitors.

The first clopidogrel generics were marketed at the beginning of October 2009 and sanofi-aventis introduced this communication strategy from September 2009 to January 2010, at the exact time when clopidogrel generics were introduced in to the market.

The action by sanofi-aventis was found to have substantially curbed the substitution process of Plavix by generics. Investigation showed that the substitution rate for Plavix follows an atypical pattern (experiencing a steady decline for numerous months after the initial increase immediately after generics were introduced) compared to similar molecules, e.g. omeprazole, simvastatin. The expected penetration rate for clopidogrel generics at the end of December 2010 was also lower than expected, being only 65%, rather than 75%.

The practices used by sanofi-aventis have also created uncertainty about the quality and safety of generics, without any evidence, since nothing shows that Plavix’s competing generics are less safe than the originator [1]. And indeed, although given the opportunity to submit supporting evidence, sanofi-aventis did not bring to the attention of the French competition authority any evidence to support its claims of the inferior quality and safety of clopidogrel generics.

Plavix was the world’s second biggest selling drug, and had sales of more than Euros 2 billion in 2010 for sanofi-aventis.

The French competition authority found that sanofi-aventis had abused its dominant position in the French market for clopidogrel and that the company’s practices were particularly serious, justifying the Euros 40.6 million fine imposed on the company.

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References

1. Baumgärtel C. Generic clopidogrel–the medicines agency’s perspective. Generics and Biosimilars Initiative Journal (GaBI Journal). 2012;1(2):89-91. doi:10.5639/gabij.2012.0102.019

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Source: L’Autorité de la concurrence