Articles

Commentary

Published on 24 April 2013

Commentary on the recommendations of the European Society for Organ Transplantation Advisory Committee on generic substitution of immunosuppressive drugs

Abstract: In 2010, the Council of the European Society for Organ Transplantation formed an Advisory Committee to formulate recommendations on the use of generic drugs in solid organ transplant recipients....

Author(s): Professor Teun van Gelder, MD, PhD

ciclosporin, generics substitution, immunosuppression, mycophenolate, tacrolimus, transplantation

DOI: 10.5639/gabij.2013.0203.031

23.577 views

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Review Article

Published on 24 April 2013

Safety and toxicity of biosimilars—EU versus US regulation

Author byline as per print journal: Tobias Blank, PhD, Tilo Netzer, PhD, Wolfram Hildebrandt, MSc, MA, Angela Vogt-Eisele, PhD, Professor Marietta Kaszkin-Bettag, PhD Background: As patents for biological drugs begin...

Author(s): Angela Vogt-Eisele, PhD, Professor Marietta Kaszkin-Bettag, PhD, Tilo Netzer, PhD, Wolfram Hildebrandt, MSc, MA, Tobias Blank, PhD

biosimilar regulation, biosimilar safety (EU USA), biosimilar toxicity, immunogenicity, pharmacovigilance, traceability

DOI: 10.5639/gabij.2013.0203.039

35.080 views

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Regulatory

Published on 24 April 2013

Biosimilar development and regulation in Japan

Abstract: In Japan, biosimilars guidelines following the principles of the EU framework were established by Japan’s Ministry of Health, Labor and Welfare in March 2009. The guidelines cover the manufacturing...

Author(s): GaBI Journal Editor

biosimilar, Japan, regulatory

DOI: 10.5639/gabij.2013.0204.055

17.116 views

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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, policy, volume

DOI: 10.5639/gabij.2013.0204.051

63.138 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

11.134 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

26.642 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

19.842 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

8.544 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

6.432 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

13.660 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

9.932 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

42.393 views

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