Articles

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

42.633 views

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Original Research

Published on 06 March 2013

How do regional sickness funds encourage more rational use of medicines, including the increase of generic uptake? A case study from Austria

Objective: To analyse similarities and differences between activities carried out by Austrian sickness funds to encourage more rational use of medicines, including increasing generics uptake. Methods: Semi-structured interviews with pharmacoeconomic...

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

generics, generics uptake, medicines, monitoring, prescribing, rational use of medicines, sickness funds

DOI: 10.5639/gabij.2013.0202.027

42.453 views

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Review Article

Published on 25 September 2013

Steps to ensure adequate supply of biological medicines: considerations for the healthcare provider

Author byline as per print journal: Andrew Mica, MBA, Martha Mutomba, PhD, Larry Green, PharmD Introduction: When drug shortages occur, healthcare providers (HCPs) often must ration drugs, cancel or delay...

Author(s): Andrew Mica, MBA, et al.

biological, drug shortages, healthcare provider, manufacturing, supply chain

DOI: 10.5639/gabij.2013.0203.038

41.787 views

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Review Article

Published on 21 February 2012

A patient-centred paradigm for the biosimilars market

Abstract: The advent of similar biological medicinal products or ‘biosimilars’ in Europe in the 2000s has led to development of a global biosimilars market and regulatory frameworks designed specifically for...

Author(s): James N Class, PhD, Lauren Langis, JD

biosimilars, medical devices, outcomes, patients, prescribers, public policy

DOI: 10.5639/gabij.2012.0101.006

41.582 views

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Review Article

Published on 21 February 2012

A review of patient perspectives on generics substitution: what are the challenges for optimal drug use

Author byline as per print journal: Helle Håkonsen, MScPharm, PhD; Else-Lydia Toverud, MScPharm, PhD Introduction: With a few exceptions, generic drug use has been promoted in western countries by allowing pharmacists to...

Author(s): Else-Lydia Toverud, MScPharm, PhD, Helle Håkonsen, MScPharm, PhD

cost containment, generic drugs, generics prescribing, generics substitution, patient perspectives

DOI: 10.5639/gabij.2012.0101.008

40.097 views

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Original Research

Published on 16 June 2014

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;...

Author(s): Brian Godman, BSc, PhD, Steven Simoens, MSc, PhD

cancer, Europe, generic drug regulations, generics, health policies, pricing

DOI: 10.5639/gabij.2019.0802.007

38.524 views

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Review Article

Published on 19 October 2012

Assessing biosimilarity and interchangeability of biosimilar products under the Biologics Price Competition and Innovation Act

Author byline as per print journal: Professor Shein-Chung Chow, PhD, Christine Ju, MSc Abstract: Biological (large molecule) drug products are made via living systems and are complex and variable in nature....

bioequivalence, biosimilarity, BPCIA, follow-on biologics, interchangeability

DOI: 10.5639/gabij.2013.0201.004

37.437 views

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Editorial

Published on 02 May 2012

Equal protection under the law: Children and the Best Pharmaceuticals for Children Act

Abstract:  Four changes to the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act will markedly improve these programmes: expanded attention paid to neonatal studies, support for the...

Author(s): Professor Daniel Kelly Benjamin Jr, MD, MPH, PhD, Professor Gregory L Kearns, PharmD, PhD

Best Pharmaceuticals for Children Act, clinical studies, legislation, neonates, off-patent drugs

DOI: 10.5639/gabij.2012.0102.014

37.418 views

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Perspective

Published on 10 February 2012

Generic clopidogrel–the medicines agency’s perspective

Abstract:  A number of generic products containing clopidogrel as the active substance have been marketed in Austria and the EU for some time. Due to different clopidogrel salt preparations and different indications, doubts...

Author(s): Christoph Baumgärtel, MD, MSc

bioequivalence, clopidogrel, drug substitution, drugs, generics, therapeutic equivalence

DOI: 10.5639/gabij.2012.0102.019

37.277 views

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Opinion

Published on 30 September 2013

Pathway to affordable, quality-assured sources of pegylated interferon alpha for treating hepatitis C

Author byline as per print journal: Barbara Milan, Sara Gaspani Introduction: The current pipeline of promising oral hepatitis C drugs could lead to a revolution in treatment for this disease...

Author(s): Barbara Milani, Sara Gaspani

biosimilars, competition, drug regulation, hepatitis C, pegylated interferon alpha, prices

DOI: 10.5639/gabij.2013.0204.053

37.209 views

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Review Article

Published on 21 February 2012

Payers endorse generics to enhance prescribing efficiency: impact and future implications, a case history approach

Author byline as per print journal: Brian Godman1,2,3, BSc, PhD; Mohammed Abuelkhair4, PharmD; Agnes Vitry5, PharmD, PhD; Shajahan Abdu4, MD; Marion Bennie6,7, MSc; Iain Bishop7, BSc; Sahar Fahmy4, PhD; Kristina Garuoliene8,...

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

demand-side measures, generics, pharmaceuticals, pricing

DOI: 10.5639/gabij.2012.0102.017

36.626 views

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Original Research

Published on 24 March 2015

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,...

Author(s): Brian Godman, BSc, PhD, Hye-Young Kwon, BPharm, MPH, PhD, Ljiljana Sović Brkičić, MPharm, Martina Bogut, BSc, Miron Sršen, MD, Tonko Tabain, MD, Winnie de Bruyn, BSc

biosimilars, Croatia, generics, pharmaceuticals, reference pricing system, reforms

DOI: 10.5639/gabij.2015.0402.017

36.625 views

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