Articles

Review Article

Published on 24 April 2013

Understanding the components of pharmaceutical expenditure—overview of pharmaceutical policies influencing expenditure across European countries

Aim: To explain the components of pharmaceutical expenditure and illustrate the strengths and limitations of this indicator. In particular, we explore policies applied in European countries that affect the price...

Author(s): Claudia Habl, Sabine Vogler, PhD, Nina Zimmermann, MA

health expenditures, hospital sector, medicine prices, pharmaceutical expenditure, policies, volume

DOI: 10.5639/gabij.2013.0204.051

63.044 views

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Special Report

Published on 14 December 2016

Overview of the patent expiry of (non-)tyrosine kinase inhibitors approved for clinical use in the EU and the US

Author byline as per print journal: Subramanian Venkatesan, MSc; Associate Professor Martine Lamfers, PhD; Professor Sieger Leenstra, MD, PhD; Professor Arnold G Vulto, PharmD, PhD, FCP Abstract: Kinase inhibitors form the...

Author(s): Associate Professor Martine Lamfers, PhD, Professor Arnold G Vulto, PharmD, PhD, FCP, Professor Sieger Leenstra, MD, PhD, Subramanian Venkatesan, MSc

anticancer drugs, kinase inhibitors, market exclusivity, patent expiry, targeted therapies

DOI: 10.5639/gabij.2017.0602.016

58.837 views

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Review Article

Published on 21 February 2012

European payer initiatives to reduce prescribing costs through use of generics

Author byline as per print journal:  Brian Godman1,2,3, BSc, PhD; Bjorn Wettermark1,4, MSc, PhD; Iain Bishop5, BSc; Thomas Burkhardt6, MSc; Jurij Fürst7, PhD; Kristina Garuoliene8, MD; Ott Laius9, MScPharm; Jaana E Martikainen10,...

Author(s): Brian Godman, BSc, PhD, et al.

demand measures, generics, pharmaceuticals, pricing

DOI: 10.5639/gabij.2012.0101.007

56.886 views

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Special Report

Published on 10 April 2012

The impact of pharmaceutical pricing and reimbursement policies on generics uptake: implementation of policy options on generics in 29 European countries─an overview

Introduction: To describe pharmaceutical pricing and reimbursement systems in 29 European countries with regard to medicines, particularly generics, and their possible impact on generics uptake. Method: Data collection on pharmaceutical pricing and...

Author(s): Sabine Vogler, PhD

generics policies, generics substitution, INN prescribing, pricing, reference pricing system, reimbursement

DOI: 10.5639/gabij.2012.0102.020

56.752 views

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Meeting Report

Published on 30 September 2013

The authorization of non-biological complex drugs (NBCDs) follow-on versions: specific regulatory and interchangeability rules ahead?

Author byline as per print journal: Professor Stefan Mühlebach, PhD, Professor Arnold Vulto, PharmD, PhD, Jon SB de Vlieger, PhD, Vera Weinstein, PhD, Beat Flühmann, PhD, Vinod P Shah, PhD...

Author(s): Beat Flühmann, PhD, Jon SB de Vlieger, PhD, Professor Arnold G Vulto, PharmD, PhD, FCP, Professor Stefan Mühlebach, PhD, Vera Weinstein, PhD, Vinod P Shah, PhD

glatiramoids, iron sucrose, liposomes, nanomedicines, NBCD, similars

DOI: 10.5639/gabij.2013.0204.054

55.394 views

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Review Article

Published on 08 October 2020

Pharmaceutical Data Integrity: issues, challenges and proposed solutions for manufacturers and inspectors

Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock1, BSc (Pharm), MSc; Vernon Tay1, BSc (Pharm) (Hons); Vimal Sachdeva2, MSc; Associate Professor Chan Lai Wah1, BSc (Pharm)...

Author(s): Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc, Associate Professor Chan Lai Wah, BSc (Pharm) (Hon), PhD, Vernon Tay, BSc (Pharm) (Hons), Vimal Sachdeva, MSc

ALCOA-plus, audit trail, blockchain technology, computerized system, cooperation, data integrity

DOI: 10.5639/gabij.2020.0904.028

53.736 views

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Original Research

Published on 10 March 2017

What pricing and reimbursement policies to use for off-patent biologicals in Europe? – results from the second EBE biological medicines policy survey

Author byline as per print journal: Jean-Baptiste Reiland, MSc; Barbara Freischem; Alexander Roediger, MA Introduction/Study objective Biosimilar policies with a focus on uptake have received a lot of attention at national...

Author(s): Alexander Roediger, MA, Executive MBA, Barbara Freischem, Jean-Baptiste Reiland, MSc

biological medicines, biosimilars, off-patent market, pricing and reimbursement policy

DOI: 10.5639/gabij.2017.0602.014

48.602 views

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Regulatory

Published on 17 January 2018

Regulations for biotherapeutics approval in Colombia

Author byline as per print journal: Johanna Andrea García Cortes, MSc; Francisco Javier Sierra Esteban, MSc Abstract: Colombia is in the process of implementing legislation to allow for the approval...

Author(s): Francisco Javier Sierra Esteban, MSc, Johanna Andrea García Cortes, MSc

abbreviated comparability, biotherapeutics approval, Colombia, INVIMA

DOI: 10.5639/gabij.2018.0701.006

46.265 views

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Original Research

Published on 02 July 2012

Saving money in the European healthcare systems with biosimilars

Introduction: The use of biotechnological manufactured drugs, or biologicals, has increased massively over the past few years. Used especially in the treatment of cancer and other severe diseases, biologicals incur high...

Author(s): Robert Haustein, Christoph de Millas, Ariane Höer, MD, Professor Bertram Häussler, MD

biologicals, biosimilars, cost savings, costs, epo, Europe, G-CSF, MAB

DOI: 10.5639/gabij.2012.0103-4.036

44.263 views

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Letters to the Editor

Published on 30 April 2013

Access to liposomal generic formulations: beyond AmBisome and Doxil/Caelyx

Abstract: The lack of clear regulatory guidance remains a key bottleneck for securing a second quality-assured source of liposomal amphotericin B (LAmB), the WHO-recommended drug for visceral leishmaniasis. The approval...

Author(s): Barbara Milani, Sara Gaspani

drug access, generics, liposomal amphotericin B, liposomal doxorubicin, visceral leishmaniasis

DOI: 10.5639/gabij.2013.0202.022

42.411 views

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