Articles

Pharma News

Published on 26 March 2014

New EU guidance for the evaluation of medicinal products with modified drug release will be finished by the middle of 2014

Submitted: 2 March 2014; Revised: 7 March 2014; Accepted: 8 March 2014; Published online first: 21 March 2014 The guideline โ€˜Note for guidance on modified release oral and transdermal dosage...

Author(s): Christoph Baumgรคrtel, MD, MSc, Jan Neuhauser, MD

DOI: 10.5639/gabij.2014.0302.024

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Original Research

Published on 24 March 2014

Biosimilars naming, label transparency and authority of choice โ€“ survey findings among European physicians

Introduction: A survey of the views of European physicians on familiarity of biosimilar medicines has demonstrated the need for distinguishable non-proprietary names to be given to all biologicals. Methods: The...

Author(s): Michael S Reilly, Esq, Richard O Dolinar, MD

biological, biosimilar, Europe, INN, pharmacy substitution, prescribers

DOI: 10.5639/gabij.2014.0302.018

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Original Research

Published on 24 March 2014

Perceptions of physicians from private medical centres in Malaysia about generic medicine usage: a qualitative study

Introduction: The healthcare sector is one of the most rapidly expanding and dynamic industries in the world. Pharmaceutical expenditure is now growing faster than other components of healthcare overheads. Globally,...

Author(s): Muhamad Ali SK Abdul Kader, MD, Rohit Kumar, MPharm, Mohamed Azmi Ahmad Hassali, PhD, Navneet Kaur, PhD

generics, Malaysia, perceptions, pharmaceuticals, private hospitals

DOI: 10.5639/gabij.2014.0302.019

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Abstracted Scientific Content

Published on 24 March 2014

Weighing up the cost of switching to biosimilars

It is far from clear whether off-patent biological medicines can offer the same cost savings as those offered by off-patent non-biological (chemically derived) medicines, write a group of Brussels-based health...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2014.0302.025

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Review Article

Published on 24 March 2014

Tyrosine kinase inhibitors becoming generic drugs โ€“ risks and chances from a regulatory perspective

Author byline as per print journal:ย Niels Eckstein, PhD;ย Lea Rรถper, BSc;ย Bodo Haas, PhD;ย Henrike Potthast, PhD;ย Ulrike Hermes, PhD;ย Christoph Unkrig, MD;ย Frauke Naumann-Winter, PhD;ย Harald Enzmann, MD Aim: To provide a systematic overview on: i)...

Author(s): Bodo Haas, PhD, Christoph Unkrig, MD, Frauke Naumann-Winter, PhD, Harald Enzmann, MD, Henrike Potthast, PhD, Lea Rรถper, BSc, Niels Eckstein, PhD, Ulrike Hermes, PhD

generics, narrow therapeutic index drugs, orphan drugs, product-specific bioequivalence guidance, tyrosine kinase inhibitors (TKI)

DOI: 10.5639/gabij.2014.0302.021

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Pharma News

Published on 24 March 2014

International Alliance of Patientsโ€™ Organizations toolkit for biological and biosimilar medicines

The International Alliance of Patientsโ€™ Organizations (IAPO) is an alliance of over 200 patient groups that represents the interests of patients worldwide. In November 2013, IAPO published its Information and...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2014.0304.045

7.889 views

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Perspective

Published on 24 March 2014

Subsequent entry biologics (biosimilars) in Canada: approaches to interchangeability and the extrapolation of indications and uses

Abstract: The principles Health Canada use when extrapolating the indications and uses of a biosimilar product subsequent to a single clinical trial or limited number and scope of clinical trials...

Author(s): Agnes V Klein, MD, DPH, Jian Wang, MD, PhD, Patrick Bedford, BSc, MA

biosimilar, Canada, reference biological product, subsequent entry biologics (SEBs)

DOI: 10.5639/gabij.2014.0303.033

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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

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Meeting Report

Published on 20 March 2014

1st ASEAN overview workshop on GMP for biologicals/biosimilars 2018 โ€“ Report

Introduction: The Association of Southeast Asian Nations (ASEAN) Overview Workshop on GMP for Biologicals and Biosimilars was co-organized with the Generics and Biosimilars Initiative (GaBI). This meeting was intended to...

Author(s): Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc, Elwyn Griffiths, DSc, PhD

ASEAN, biologicals, biosimilars, GMP

DOI: 10.5639/gabij.2019.0803.015

10.143 views

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Letters to the Editor

Published on 18 March 2014

Common or distinct INN for biosimilars? Only characteristics of the active substance prior to formulation should be considered

Submitted: 24 January 2014; Revised: 29 January 2014; Accepted: 30 January 2014; Published online first: 12 February 2014 To the Editor: I read with interest the letter of Dr Edward...

Author(s): Professor Paul J Declerck, PhD

DOI: 10.5639/gabij.2014.0301.003

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Editor's Letter

Published on 18 March 2014

Editorโ€™s introduction to the initial issue of the third volume of GaBI Journal

This issue of the GaBI Journal begins with editorial comments from our Deputy Editor-in-Chief Dr Robin Thorpe concerning the Review Article by Azevedo et al. covering biosimilar regulations and their...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2014.0301.001

4.210 views

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