Myths, questions, facts about generic drugs in the EU

Baumgärtel, Christoph

doi:10.5639/gabij.2012.0101.009

Cited by 24 publications

(30 citation statements)

References 7 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…However, physicians in Nigeria currently have concerns with generic substitution because of concerns with their quality including bioequivalence [37]. As a result there needs to be strategies to re-assure physicians about the quality of generics through for instance measures to ensure the instigation of good manufacturing practices for locally sourced and imported generics in Nigeria to meet the strict bioequivalence criteria seen in Europe before they receive marketing authorisation [47]. These strategies are important to ensure that patients receive the full health benefit from generic medicines including generic statins.…”

Section: Discussionmentioning

confidence: 99%

Statin prescribing among hypertensive patients in southwest Nigeria: findings and implications for the future

et al. 2016

View full text Add to dashboard Cite

This version is available at https://strathprints.strath.ac.uk/54803/ Strathprints is designed to allow users to access the research output of the University of Strathclyde. Unless otherwise explicitly stated on the manuscript, Copyright © and Moral Rights for the papers on this site are retained by the individual authors and/or other copyright owners. Please check the manuscript for details of any other licences that may have been applied. You may not engage in further distribution of the material for any profitmaking activities or any commercial gain. You may freely distribute both the url (https://strathprints.strath.ac.uk/) and the content of this paper for research or private study, educational, or not-for-profit purposes without prior permission or charge.Any correspondence concerning this service should be sent to the Strathprints administrator: strathprints@strath.ac.ukThe Strathprints institutional repository (https://strathprints.strath.ac.uk) is a digital archive of University of Strathclyde research outputs. It has been developed to disseminate open access research outputs, expose data about those outputs, and enable the management and persistent access to Strathclyde's intellectual output. Atorvastatin was the most prescribed statin, followed by simvastatin, rosuvastatin and finally fluvastatin. Prescribed doses were less than 1 defined daily dose in the majority, with high use of originators.

show abstract

Section: Discussionmentioning

confidence: 99%

Statin prescribing among hypertensive patients in southwest Nigeria: findings and implications for the future

et al. 2016

View full text Add to dashboard Cite

show abstract

“…This especially with global sales of pharmaceutical products likely to lose their patents between 2008 and 2013 estimated at US$50-100bn (€35-70), and US$255bn between 2011 and 2016, out of total pharmaceutical sales of US$820bn in 2009 (€579bn) including US$700bn from OECD countries [6][7][8][9][10]15,[67][68][69], and generic substitution estimated to reduce costs to patients by an average of 60% in middle income countries alone [17,70]. As a result, present considerable opportunities for European countries to learn from each other to [6,8,10,15,40,81]. The predefined acceptance limits for bioequivalence for different batches of generics ensure that plasma concentrations vary only by 3-4% on average from those of the originator, i.e.…”

Section: Introductionmentioning

confidence: 99%

“…The predefined acceptance limits for bioequivalence for different batches of generics ensure that plasma concentrations vary only by 3-4% on average from those of the originator, i.e. the same for different batches of the originator, which is seen as clinically irrelevant in the vast majority of situations [81,82]. As a result, health authority and health insurance company personnel typically assume that if two medicines have the same bioavailability they should have a similar therapeutic effect.…”

Section: Introductionmentioning

confidence: 99%

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

Godman

Bennie

Baumgärtel³

et al. 2012

Self Cite

112

View full text Add to dashboard Cite

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.

show abstract

“…Korea . off-patent drugs Generics are therapeutically equivalent to originator medicines but less costly at appropriate doses [1,2]. Once a generic is available, the monopolistic market for an originator medicine becomes more competitive.…”

mentioning

confidence: 99%

The impact of South Korea’s new drug-pricing policy on market competition among off-patent drugs

Kwon

Kim

Godman

et al. 2015

Expert Review of Pharmacoeconomics & Outcomes Research

View full text Add to dashboard Cite

show abstract

Myths, questions, facts about generic drugs in the EU

Cited by 24 publications

References 7 publications

Statin prescribing among hypertensive patients in southwest Nigeria: findings and implications for the future

Statin prescribing among hypertensive patients in southwest Nigeria: findings and implications for the future

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

The impact of South Korea’s new drug-pricing policy on market competition among off-patent drugs

Contact Info

Product

Resources

About