Articles

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

11.246 views

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Original Research

Published on 24 April 2013

Assessing biosimilarity using the method of generalized pivotal quantities

Author byline as per print journal: Shih-Ting Chiu, PhD, Chen Chen, MSc, Professor Shein-Chung Chow, PhD, Eric Chi, PhD Introduction: For generic approval of small-molecule (chemical) drug products, US Food...

Author(s): et al., Shih-Ting Chiu, MSc

extra-reference design, generalized pivotal quantity, individual bioequivalence, replicated crossover design

DOI: 10.5639/gabij.2013.0203.037

26.688 views

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Original Research

Published on 22 April 2013

Regional tenders on biosimilars in Italy: potentially competitive?

Author byline as per print journal: Alessandro Curto, MSSc, Katelijne Van de Vooren, MSc, Roberta Lo Muto, MSc, Silvy Duranti, MBA, Professor Livio Garattini Introduction: Health care in Italy is...

Author(s): Alessandro Curto, MSSc, Katelijne Van de Vooren, MSc, Professor Livio Garattini, Roberta Lo Muto, MSc, Silvy Duranti, MBA

biosimilars, competition, Italy, regions, tender

DOI: 10.5639/gabij.2013.0203.036

19.970 views

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Guidelines

Published on 19 April 2013

EORTC continues to support the appropriate treatment of adult patients with G-CSF to prevent febrile neutropenia: guideline updates

Abstract:  The European Organisation for Research and Treatment of Cancer (EORTC) has updated its 2006 guideline on the use of granulocyte colony-stimulating factor (G-CSF) for the prevention of febrile neutropenia...

Author(s): GaBI Journal Editor

febrile neutropenia, G-CSF, leukaemia, lymphoma, myelosuppression, risk

DOI: 10.5639/gabij.2013.0201.016

8.581 views

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Editor's Letter

Published on 19 April 2013

Editor’s introduction to the wide range of topics in the initial issue of the second volume of GaBI Journal

We start off the second year of GaBI Journal with articles covering a wide range of issues. In Letters to the Editor, Dr Christian K Schneider discusses and expands on...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2013.0201.015

6.448 views

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Letters to the Editor

Published on 18 April 2013

Challenges to generic medicines utilization in Yemeni healthcare system

Abstract: Generic medicines are promoted in many countries as an essential part of the healthcare system. However, in Yemen, there are many challenges to the utilisation of generic medicines. Currently,...

Author(s): Saleh Karamah AL-Tamimi, BPharm, MPharm (ClinPharm), Mohamed Azmi Ahmad Hassali, PhD, Alian A Alrasheedy, BPharm(Hons), MPharm(Clin), BCPS

challenges, consumers, generic medicines, healthcare professionals, Yemen

DOI: 10.5639/gabij.2013.0202.017

13.773 views

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Editorial

Published on 13 March 2013

Health authority perspective on biosimilars

Abstract: Dr Brian Godman reviews Mr Gustaf Befrits’ paper on the case for biosimilars from a payer’s perspective. Biosimilars are increasingly important to payers with growing resource pressures. However, key...

Author(s): Brian Godman, BSc, PhD

biosimilars, economics

DOI: 10.5639/gabij.2013.0201.010

9.982 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

42.488 views

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Perspective

Published on 06 March 2013

Equivalence of generic medicines in general and immunosuppressants in particular – a regulatory opinion on switching of ciclosporin, tacrolimus and mycophenolate mofetil

Abstract: This position paper deals with our regulatory opinion on registered generic immunosuppressants such as ciclosporin, tacrolimus and mycophenolate mofetil, and provides arguments why these medicines are considered equally safe...

Author(s): Marc Maliepaard, PhD, Yang Yu, PharmD, Professor Hubert GM Leufkens, PharmD, PhD

bioequivalence, drug safety, generics, immunosuppression, regulation

DOI: 10.5639/gabij.2013.0202.019

24.616 views

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Pharma News

Published on 07 February 2013

‘Similar biologics’ approved and marketed in India

There have been established guidelines for approving generic versions of small molecule chemical drugs in India for some time already. However, no specific guidelines for ‘similar biologics’, as the Indian...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2013.0201.006

13.289 views

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Perspective

Published on 11 January 2013

Biosimilarity in Latin America

Abstract: The introduction of new legislation in Latin America for the approval of biosimilar products follows implementation of EU legislation in 2005 for biosimilars approval. The establishment of regulatory processes...

Author(s): Chang Chiann, PhD, Leonardo de Souza Teixeira, PhD, Fabiana Fernandes de Santana e Silva Cardoso, MSc, Isabela da Costa César, PhD, Gerson Antônio Pianetti, PhD

biosimilarity, complex drugs, Latin America

DOI: 10.5639/gabij.2013.0202.021

20.827 views

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