Articles

Meeting Report

Published on 12 June 2017

Pharmacovigilance, traceability and building trust in biosimilar medicines

Author byline as per print journal: Professor Teun van Gelder, MD, PhD; Benedicte Lunddahl, DVM; Professor Barbara OM Claus, PharmD, PhD Abstract: The Medicines for Europe’s Biosimilar Medicines Group met at the...

Author(s): Barbara OM Claus, PharmD, PhD, Benedicte Lunddahl, DVM, Professor Teun van Gelder, MD, PhD

biological, biosimilar, European Union, pharmacovigilance, regulatory, traceability

DOI: 10.5639/gabij.2017.0603.026

11.816 views

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Pharma News

Published on 06 March 2015

Top developments in biosimilars during 2014

Submitted: 10 February 2015; Revised: 24 February 2015; Accepted: 25 February 2015; Published online first: 6 March 2015 The past year has once again been a busy one for the...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2015.0401.010

11.678 views

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Perspective

Published on 13 February 2012

Generic and therapeutic orphans

Abstract:  This commentary discusses the need to develop methods to ensure the availability of non-profitable, off-patent medicines to children and other populations. The history and some of the shortcomings of...

Author(s): Professor Philip D Walson, MD

off-patent drugs, orphan, paediatric

DOI: 10.5639/gabij.2012.0101.010

11.616 views

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Editor's Letter

Published on 05 December 2013

GaBI Journal publishes four issues in 2013

This issue marks the forth and final issue of the second year’s edition of the GaBI Journal. The journal has grown rapidly through the combined efforts of the publisher and...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2013.0204.042

11.609 views

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Pharma News

Published on 06 September 2017

Top developments in biosimilars during 2017

Submitted: 30 January 2018; Revised: 8 February 2018; Accepted: 12 February 2018; Published online first: 26 February 2018 The past year has once again been a busy one for the...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2018.0701.008

11.572 views

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Regulatory

Published on 14 June 2018

Biosimilar regulation and approval in Jordan

Author byline as per print journal: Rana Musa Ali Al-ali “Malkawi”, MSc; Wesal Salem Al Haqaish, BPharm; Hayel Obeidat, MD Abstract: The regulatory oversight of medicinal products in Jordan is...

Author(s): Hayel Obeidat, MD, Rana Musa Ali Al-ali “Malkawi”, MSc, Wesal Salem Al-haqaish, BPharm

biological, biosimilar, EMA, INN, Jordan FDA, regulation

DOI: 10.5639/gabij.2018.0702.016

11.430 views

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Original Research

Published on 20 March 2014

Stability of the trastuzumab biosimilar ABP 980 compared to reference product after intravenous bag preparation, transport and storage at various temperatures, concentrations and stress conditions

Author byline as per print journal: Shon Crampton1, BA; Alla Polozova1, PhD; Darin Asbury2, BS; Alexis Lueras2, BS; Paul Breslin1, BS; Jane Hippenmeyer3, PharmD; Jennifer Litowski1, PhD; Monica Goss2, PhD...

ABP 980, biosimilar, stability, trastuzumab

DOI: 10.5639/gabij.2020.0901.002

11.400 views

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Legal

Published on 16 June 2014

Biosimilars: considerations in light of the Italian legal framework

Abstract: Biological and biotechnological medicines are important pharmaceutical innovations due to their influence on the treatment of many conditions and because they have led the way in devising new and...

Author(s): Enrico Adriano Raffaelli, LLB, JD, Fausto Massimino, LLB, JD

advertising, biosimilars, competition, Italy, public tenders, scientific information

DOI: 10.5639/gabij.2019.0801.002

11.394 views

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Commentary

Published on 16 December 2014

The EU regulatory approach to generics and biosimilars is essentially similar

Abstract: Notwithstanding the scientific and regulatory differences between generic and biosimilar medicines, the European Medicines Agency/Committee for Medicinal Products for Human Use has consistently applied a ‘same active substance’ approach...

Author(s): Barbara J van Zwieten-Boot, Marcel Hoefnagel, Peter MJM Jongen, R Martijn van der Plas

active substance, biosimilar, EMA, Europe, guidelines, regulatory

DOI: 10.5639/gabij.2015.0401.004

11.265 views

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Commentary

Published on 31 March 2017

Patent expiry and costs for anti­cancer medicines for clinical use

Author byline as per print journal: Brian Godman, BSc, PhD; Claudia Wild, PhD; Alan Haycox, PhD Abstract: Venkatesan S et al. have researched patent rights and pricing for (non-)tyrosine kinase inhibitors....

Author(s): Alan Haycox, PhD, Brian Godman, BSc, PhD, Claudia Wild, PhD

cancer medicines, generics, health gain, prices, tyrosine kinase inhibitors (TKI)

DOI: 10.5639/gabij.2017.0603.021

11.243 views

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Meeting Report

Published on 06 August 2019

2nd MENA Stakeholder Meeting on Biosimilars 2018 – Report

Introduction: The number of biosimilars, or similar biotherapeutic products, is expanding rapidly worldwide. A further 12 blockbuster biologicals are set to add to this number by 2020. Agreement about the...

Author(s): Andrea Laslop, MD, Jian Wang, MD, PhD, Robin Thorpe, PhD, FRCPath

biosimilars, costs, MENA (Middle East and North Africa), pharmacovigilance, regulators, switching

DOI: 10.5639/gabij.2019.0802.009

11.160 views

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