The implementation of generics in France

Abstract: The first recognized and trusted generic drugs were launched in France in 1995, at the same time that the Prime Minister Alain Juppé introduced his new plan on Retirement and Social Security. It has taken 20 years for generic drugs to become integrated into the pharmacy community, and for acceptance to be reached by […]


Generic pregabalin; current situation and implications for health authorities, generics and biosimilars manufacturers in the future

Author byline as per print journal: Brian Godman, BSc, PhD; Michael Wilcock, MPharm; Andrew Martin, MPharm; Scott Bryson, MSc, MPH; Christoph Baumgärtel, MD; Tomasz Bochenek, MD, MPH, PhD; Winne de Bruyn, BSc; Ljiljana Sović Brkičić, MPharm; Marco D’Agata, MSc; Antra Fogele, PhD; Anna Coma Fusté, MSc; Jessica Fraeyman, PhD; Jurij Fürst, MD; Kristina Garuoliene, MD, PhD; Harald Herholz, MD, […]


The refinement of the super generic concept: semantic challenge for product re-innovation?

Background: Uptake of super generic or hybrid pharmaceuticals has decelerated despite their important economic potential for the generic pharmaceutical industry. The aim of switching to these product portfolios was to enable product differentiation; however, these strategies are influenced by new semantic challenges, which have hampered the promotion of value-added pharmaceuticals or super generics in recent […]


Pharmaceutical pricing in Croatia: a comparison of ordinances in 2013 versus 2009 and their potential savings to provide future guidance

Author byline as per print journal: Ljiljana Sović Brkičić, MPharm; Brian Godman, BSc, PhD; Martina Bogut, BSc; Miron Sršen, MD; Hye-Young Kwon, BPharm, MPH, PhD; Winnie de Bruyn, BSc; Tonko Tabain, MD Introduction: Croatia has introduced a number of reforms to contain pharmaceutical expenditure whilst increasing access to new medicines. These include new regulations and new […]


Differences in pharmacokinetic behaviour of branded enoxaparin and a US generic version in a non-human primate model

Author byline as per print journal: Professor Walter P Jeske, PhD; Jeanine M Walenga, PhD; Nicolas Simon, MD, PhD; Debra Hoppensteadt, PhD; Josephine Cunanan, MD; Vicki Escalante, BS; Jawed Fareed, PhD; Mamdouh Bakhos, MD Introduction: Low molecular weight heparins (LMWHs) are composed of a heterogeneous mixture of oligosaccharides that express a spectrum of biological activities. Studies […]


Availability and procurement of generics in hospitals among medium-sized European countries

Abstract: Dr Brian Godman reviews the paper by Vogler and co-authors on the procurement of generics or originators among European hospitals once multiple sources become available. Submitted: 28 November 2014; Revised: 3 December 2014; Accepted: 3 December 2014; Published online first: 16 December 2014 Vogler and co-authors have provided valuable insight into the procurement of […]


Availability and procurement conditions of originator and generic medicines in hospitals – an exploratory study in five medium-sized European countries

Aim: To explore whether medicines used in hospitals in European countries are supplied as originators or generic medicines, and to investigate the procurement conditions, including the extent of discounts at which the medicines are provided. Methodology: In September 2009, we collected primary data for four commonly used medicines in 25 public hospitals in five medium-sized […]


Pricing of oral generic cancer medicines in 25 European countries; findings and implications

Author byline as per print journal: Brian Godman1,2,3,4, BSc, PhD; Andrew Hill5; Professor Steven Simoens6, MSc, PhD; Amanj Kurdi1,7, BSc, PhD; Jolanta Gulbinovič8, MD, PhD; Antony P Martin2,9; Angela Timoney1,10; Dzintars Gotham11, MBBS; Janet Wale12; Tomasz Bochenek13, MD, PhD; Celia C Rothe13; Iris Hoxha14; Admir Malaj15; Christian Hierländer16; Robert Sauermann16, MD; Wouter Hamelinck17; Zornitza Mitkova18; […]


Ongoing initiatives to improve prescribing efficiency in China; statins as a case history

Author byline as per print journal: Wenjie Zeng, BSc, PhD; Houmei Xi, B Eng; Brian Godman, BSc, PhD; Alexander E Finlayson, MD, MRCP;  Rickard E Malmstrom, MD, PhD Introduction: Pharmaceutical expenditure rose by 16% per annum in China during the past decade, and now represents 46% of total healthcare expenditure. Initiatives to moderate growth include pricing […]


Perceptions of physicians from private medical centres in Malaysia about generic medicine usage: a qualitative study

Introduction: The healthcare sector is one of the most rapidly expanding and dynamic industries in the world. Pharmaceutical expenditure is now growing faster than other components of healthcare overheads. Globally, pressures to manage pharmaceutical spending have led to increased prescribing of generic drugs. Use of generic drugs in private medical centres in Malaysia, however, remains […]


Tyrosine kinase inhibitors becoming generic drugs – risks and chances from a regulatory perspective

Author byline as per print journal: Niels Eckstein, PhD; Lea Röper, BSc; Bodo Haas, PhD; Henrike Potthast, PhD; Ulrike Hermes, PhD; Christoph Unkrig, MD; Frauke Naumann-Winter, PhD; Harald Enzmann, MD Aim: To provide a systematic overview on: i) safety profiles; ii) pharmacokinetic parameters; and iii) regulatory framework of anti-cancer tyrosine kinase inhibitors (TKI). Methodology: Recherché of pharmakokinetic (PK)-parameter: i) Germany’s federal drug database […]


New product-specific bioequivalence guidance

Abstract: For harmonization of the authorization requirements for specific generic applications within the EU, consistent criteria were drafted for 16 active substances, which are out now for public consultation. Submitted: 2 January 2014; Revised: 6 January 2014; Accepted: 7 January 2014; Published online first: 20 January 2014 Official draft guidance has recently become available for […]