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

Baumgärtel, Christoph; Godman, Brian; Vitry, Agnès; Ringerud, Anne Marthe; Sermet, Catherine; Zara, Corrine; Koskinen, Hanna; Herholz, Harald; Bennie, Marion

doi:10.5639/gabij.2012.0102.016

Cited by 31 publications

(38 citation statements)

References 25 publications

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“…Responding to efforts by the originator company to retain sales, authorities adopted 'pragmatic approaches' to enhance generics prescribing, e.g. mandatory generics substitution, educational activities, see Table 2 [23,24]. Still, the differences in the reimbursed prices of generic clopidogrel versus the originator were high across Europe, especially briefl y after launch, but decreasing over time.…”

Section: Somementioning

confidence: 99%

The potential of generics policies: more room for exploitation–PPRI Conference Report

Vogler¹

2012

GaBI J

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Section: Somementioning

confidence: 99%

The potential of generics policies: more room for exploitation–PPRI Conference Report

Vogler¹

2012

GaBI J

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“…In addition, potentially liberating monies to fund new innovative drugs [6][7][8][9][10][11]40,71,72]. However, this philosophy has not always been followed by individual companies, some of whom try and manipulate the market to maintain sales of their originator products for as long as possible [6,52,54,74]. The World Health Organization (WHO) also endorses the use of generics when discussing the rational use of medicines as well as potential strategies to release resources to help maximise health gain with available budgets [17,40,63,70,75].…”

Section: Introductionmentioning

confidence: 99%

“…The various initiatives can be divided into supply-side reforms and demand-side reforms. Supply-side reforms include measures to lower the price of generics, accelerate their marketing authorisation, reference pricing for the molecule (Anatomical Therapeutic Classification -ATC -Level 5 [76]), the class (ATC Level 4) or the therapeutic area (ATC Level 3), as well as compulsory price cuts when target budgets are being exceeded [1][2][3][4][5][6][7][8]10,11,14,15,[31][32][33][34][35]37,38,[40][41][42]44,52,77,78]. Demand-side measures include those to enhance the prescribing, requesting and dispensing of generics versus originators, as well as enhance the prescribing of generics in a class or related class versus still patented products where all drugs in the class are seen as essentially similar for all or nearly all patients [1][2][3][4][5][6][7][8][9][10][11]15,[31][32][33][34][35]…”

Section: Introductionmentioning

confidence: 99%

“…This is typically the case even when the generic is a different salt to the originator with initially different indications when first approved by the European Medicines Agency (EMA). This happened with generic clopidogrel despite the efforts of the originator company to persuade physicians to continue prescribing Plavix® [52,82,83]. This belief is strengthened by the continual monitoring of the quality of generics by EMA and regulatory authorities in member states, leading for instance to the withdrawal of some versions of generic clopidogrel when there were concerns with the manufacturing process [52,82].…”

Section: Introductionmentioning

confidence: 99%

“…This happened with generic clopidogrel despite the efforts of the originator company to persuade physicians to continue prescribing Plavix® [52,82,83]. This belief is strengthened by the continual monitoring of the quality of generics by EMA and regulatory authorities in member states, leading for instance to the withdrawal of some versions of generic clopidogrel when there were concerns with the manufacturing process [52,82]. This is illustrated by two recent literature reviews comparing the outcomes between generic and originator drugs for the treatment of different disease areas [84,85], which again failed to show any superiority of the originator [82].…”

Section: Introductionmentioning

confidence: 99%

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Essential to increase the use of generics in Europe to maintain comprehensive health care?

Godman

Bennie

Baumgärtel³

et al. 2012

Self Cite

112

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INTRODUCTION: Reforms have been introduced across Europe to increase prescribing efficiency with existing drugs. These include measures to lower prices of generics as well as increase their prescribing versus originators and patented products in a class or related class. This is essential to maintain comprehensive health care in Europe given continued pressures. The alternative is insufficient funds for new innovative drugs and increasing drug volumes with ageing populations. OBJECTIVE: To review the influence of measures and initiatives to increase the prescribing and dispensing of generics at low prices on ambulatory care prescribing efficiency. In view of this, provide guidance as authorities strive to introduce further reforms to meet their goals. METHODOLOGY: A narrative review of published papers combined with case histories. RESULTS: The different supply- and demand-side measures have reduced generic prices to as low as 2% to 3% of pre-patent loss prices in some cases as well as appreciably enhanced their utilisation. As a result, prescribing efficiency has increased without compromising care. In some cases, the reforms have led to expenditure actually falling despite appreciably increased volumes. CONCLUSIONS: Increasing use of generics at low prices will help maintain the European ideals of comprehensive and equitable health care. However, countries will continually need to learn from each other.

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Comparison of the antiplatelet effect of clopidogrel hydrogenosulfate and clopidogrel besylate in patients with stable coronary artery disease

Hamilos

Saloustros

Skalidis

et al. 2015

J Thromb Thrombolysis

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It is well known that patients with poor response to antiplatelet therapy are most likely to have more thrombotic events. Clopidogrel hydrogensulfate (CHS) is a thienopyridine acting as an important antiplatelet agent alone or in combination with acetylsalicylic acid to prevent cardiovascular complications. A different clopidogrel salt, clopidogrel besylate (CB), was recently approved as a generic drug for the same purpose while data about its antiplatelet effect are very scarce. Our study compared the antiplatelet effect of CHS and CB in patients with stable coronary artery disease. Patients with stable coronary artery disease (n = 101) (coronary lesions defined angiographically 30-70 %) were randomized to either CHS (n = 50) or CB (n = 51). After randomization a 600 mg loading dose of the drug was given and monitoring of antiplatelet effect was done 12-14 h later with VerifyNow assay. Antiplatelet response was measured with P2Y12 reaction units (PRU) and % inhibition P2Y12 from baseline (% inhibition P2Y12). Moreover CYP2C19*2, CYP2C19*3 and CYP3Α5 polymorphisms were studied in all patients. Clinical characteristics were similar between the two study groups. No significant difference was observed for baseline platelet reactivity between CHS and CB patients (258 ± 38 vs. 256 ± 38 respectively, p = 0.79). No difference was found for antiplatelet response between the CHS and the CB group, assessed by PRU (195 ± 74 vs. 204 ± 67 respectively, p = 0.51) and by % inhibition P2Y12 (24 ± 25 vs. 24 ± 22 % respectively, p = 0.95). Number of heterozygotes for CYP2C19*2 polymorphism was comparable and their platelet reactivity was similar between the two study groups. Our results indicate that both CB and CHS had an identical antiplatelet effect in patients with stable coronary artery disease. No difference on platelet reactivity of heterozygotes for CYP2C19*2 polymorphism was found between the two study groups.

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

Cited by 31 publications

References 25 publications

The potential of generics policies: more room for exploitation–PPRI Conference Report

The potential of generics policies: more room for exploitation–PPRI Conference Report

Essential to increase the use of generics in Europe to maintain comprehensive health care?

Comparison of the antiplatelet effect of clopidogrel hydrogenosulfate and clopidogrel besylate in patients with stable coronary artery disease

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