Articles

Letters to the Editor

Published on 11 October 2012

A bioethicist’s view of the use of biosimilars

Abstract:  In recognition of the many ethically sensitive issues raised by the production and use of biosimilar medicinal products, the author imagines having to answer the non-multiple choice question ‘From...

Author(s): Carlo Petrini, PhD

bioethics, drugs, ethics committees, legislation, risk, safety

DOI: 10.5639/gabij.2012.0103-4.034

12.287 views

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Perspective

Published on 27 April 2016

New monoclonal antibody biosimilars approved in 2015 in Latin America: position statement of the Latin American Forum on Biosimilars on biosimilarity, interchangeability and extrapolation of indications

Author byline as per print journal: Valderílio Feijó Azevedo1,2, Alejandra Babini3,4, Fabio Vieira Teixeira5,6, Igor Age Kos1,2, Pablo Matar7 Introduction: The Latin American Forum on Biosimilars (FLAB) is an annual...

Author(s): Alejandra Babini, Associate Professor Valderilio Feijó Azevedo, MD, PhD, MSc, Igor Age Kos, Pablo Matar, PhD, Professor Fabio V Teixeira, MSc, MD, PhD

biosimilarity, extrapolation, infliximab, interchangeability, monoclonal antibodies, rituximab

DOI: 10.5639/gabij.2016.0502.017

12.283 views

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Meeting Report

Published on 12 June 2017

Value-added medicines: how repurposed medicines bring value to patients and pharmacists

Author byline as per print journal: Christoph Stoller; Professor Stephan Krähenbühl, MD, PhD; Emilia Minodora Voiculescu, PharmD Abstract: The Value Added Medicines Group of Medicines for Europe met at the 2017 European...

Author(s): Christoph Stoller, Emilia Minodora Voiculescu, PharmD, Professor Stephan Krähenbühl, MD, PhD

innovation, pharmacy regulation, value-added medicines

DOI: 10.5639/gabij.2017.0603.027

12.247 views

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Interview

Published on 16 June 2014

Biosimilars collaboration at Amgen and Actavis

Abstract: Representatives from Amgen and Actavis have spoken to GaBI (Generics and Biosimilars Initiative) about biosimilars. Topics covered included the clinical development of biosimilars, the need for further education, how...

Author(s): GaBI Journal Editor

biosimilar, clinical development, commercializaiton, INN

DOI: 10.5639/gabij.2014.0303.035

12.224 views

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Regulatory

Published on 03 July 2012

Tighter EU rules on pharmacovigilance for biologicals

Received: 27 March 2012; Accepted: 22 May 2012 The new EU pharmacovigilance legislation which comes into force in July 2012 will include a tightening of requirements relating to product information and identification, as...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2012.0102.015

12.067 views

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Special Report

Published on 26 March 2015

Generic medicines entry into the Malaysian pharmaceutical market

Author byline as per print journal: Omotayo Fatokun, PhD; Professor Mohamed Izham Mohamed Ibrahim, PhD; Professor Mohamed Azmi Hassali, PhD Abstract: There are major barriers to generic medicine development and market...

Author(s): Omotayo Fatokun, PhD, Professor Mohamed Azmi Hassali, PhD, Professor Mohamed Izham Mohamed Ibrahim, PhD

generic medicines, Malaysia, market entry, patent, pharmaceutical market

DOI: 10.5639/gabij.2016.0504.046

12.039 views

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Commentary

Published on 14 June 2018

Medicines regulation in the MENA region and the importance of the World Health Organization’s INN proposal of Biological Qualifier

Author byline as per print journal: Peter J Pitts, BA; Michael S Reilly, Esq Abstract: The World Health Organization should finalize its Biological Qualifier guidance. Distinguishable naming will allow quick and...

Author(s): Michael S Reilly, Esq, Peter J Pitts, BA

Biological Qualifier (BQ), biosimilar, INN, medicines regulation, MENA (Middle East, North Africa), North Africa)

DOI: 10.5639/gabij.2018.0703.021

11.993 views

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Original Research

Published on 12 March 2012

Ongoing activities to influence the prescribing of proton pump inhibitors within the Scottish National Health Service: their effect and implications

Author byline as per print journal: Professor Brian Godman1,2,3, BSc, PhD; Amanj Kurdi1,4, PhD; Holly McCabe5, MSc; Sean MacBride-Stewart6, MSc; Axel Leporowski5, MD; Simon Hurding7, MD; Professor Marion Bennie1, MSc; Professor...

Author(s): Amanj Kurdi, BSc, PhD, Axel Leporowski, MD, Brian Godman, BSc, PhD, Holly McCabe, MSc, Marion Bennie, MSc, Professor Alec Morton, PhD, Sean MacBride-Stewart, MSc, Simon Hurding, MD

drug utilization, expenditure, generics, PPIs, reforms, Scottish NHS

DOI: 10.5639/gabij.2018.0704.030

11.945 views

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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

11.745 views

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