Articles

Meeting Report

Published on 29 June 2016

Reducing healthcare costs and building trust in biosimilar medicines

Author byline as per print journal: Niklas Ekman, PhD; Professor Arnold G Vulto, PharmD, PhD; Paul Cornes, MD Abstract: The increasing cost of medicines was highlighted at the Biosimilar Medicines...

Author(s): Niklas Ekman, PhD, Paul Cornes, MD, Professor Arnold G Vulto, PharmD, PhD, FCP

biological, biosimilar, cancer, European Union, healthcare costs, medicines, regulatory

DOI: 10.5639/gabij.2016.0502.020

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Original Research

Published on 26 October 2016

Naming and labelling of biologicals – the perspective of hospital and retail pharmacists

Author byline as per print journal: Professor Philip J Schneider, MS, FASHP; Michael S Reilly, Esq Introduction: To date, the US Food and Drug Administration (FDA) has offered only draft guidance...

Author(s): Michael S Reilly, Esq, Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP

ASBM, biologicals, biosimilars, labelling, naming, US Food and Drug Administration (FDA)

DOI: 10.5639/gabij.2016.0504.040

9.024 views

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Legal

Published on 08 March 2016

Biosimilars patent litigation in Canada and Japan: a comparative strategic overview and EU and US update

Abstract: Biosimilars are highly similar versions of reference biological products, some with the potential to be deemed ‘interchangeable’ by medicines regulatory bodies, such as the US Food and Drug Administration....

Author(s): Brian J Malkin, Esq, Esq

351(k), Federal Circuit, interchangeable biosimilar, Japan Pharmaceuticals and Medical Devices Agency (PMDA), patent litigation linkage, subsequent entry biologics (SEBs)

DOI: 10.5639/gabij.2016.0502.016

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Letters to the Editor

Published on 12 November 2013

Biosimilars naming and prescribing policy in Australia

Submitted: 31 October 2013; Revised: 6 November 2013; Accepted: 11 November 2013; Published online first: 25 November 2013 To the Editor: I wanted to bring to your attention the following...

Author(s): Brendan Shaw, PhD

DOI: 10.5639/gabij.2013.0204.048

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Meeting Report

Published on 31 March 2017

Roundtable on registries: practical considerations for registries – making them work, London, UK, 26 January 2017

Author byline as per print journal: Stuart Bloom, DM, FRCP; Keith Bodger, MBChB(Honours), MD, FRCP; Fraser Cummings, BMSc(Hons), MBChB, MRCP(UK), DPhil, FRCP; Professor Sarah Garner, BPharm, PhD; Professor Kimme Hyrich, MD, PhD, FRCPC; Clare...

Author(s): Clare Jacklin, Fraser Cummings, BMSc(Hons), MBChB, MRCP(UK), DPhil, FRCP, Keith Bodger, MBChB(Honours), MD, FRCP, Professor John G Williams, CBE, FRCP, Professor Kimme Hyrich, MD, PhD, FRCPC, Professor Sarah Garner, BPharm, PhD, Stuart Bloom, DM, FRCP

biologicals, biosimilars, monoclonal antibodies, pharmacovigilance, registries, regulation

DOI: 10.5639/gabij.2017.0603.025

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Abstracted Scientific Content

Published on 04 December 2013

Biosimilar monoclonal antibodies – time for a regulatory rethink

The approval of biosimilars in the European Union (EU) is governed by the EU biosimilar framework released in 2004. But new arrivals on the biosimilar stage – monoclonal antibodies –...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2013.0203.041

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Original Research

Published on 15 December 2017

Patient-reported outcome measures in phase III trials of LY2963016 insulin glargine and reference insulin glargine products: ELEMENT 1 and ELEMENT 2

Author byline as per print journal: Magaly Perez-Nieves1, MPH, PhD; Robyn K Pollom1, ANP; Ran Duan1, PhD; Samaneh Kabul1, PharmD; Amy M DeLozier1, MPH; Puneet Kaushik2, MPharm; Liza L Ilag1,...

Author(s): Amy M DeLozier, MPH, Liza L Ilag, MD, Magaly Perez-Nieves, MPH, PhD, Puneet Kaushik, MPharm, Ran Duan, PhD, Robyn K Pollom, ANP, Samaneh Kabul, PharmD

biosimilar, follow-on biological, glargine, patient-reported outcomes, type 1 diabetes mellitus, type 2 diabetes mellitus

DOI: 10.5639/gabij.2018.0702.012

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Commentary

Published on 18 March 2020

Importance of the determination of the higher order structure in the in-use stability studies of biopharmaceuticals

Abstract: Knowledge of the higher order structure of proteins is important in biopharmacological studies, such as in biosimilar comparability studies. This paper describes the analytical methods available to determine higher...

Author(s): Professor Alain Astier, PharmD, PhD

analysis, biosimilar, protein, spectroscopy, structure

DOI: 10.5639/gabij.2020.0902.009

8.926 views

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Abstracted Scientific Content

Published on 14 December 2017

Randomized non-inferiority trial fails to find inferiority switching from infliximab originator to CT-P13 biosimilar

Submitted: 17 November 2017; Revised: 20 November 2017; Accepted: 22 November 2017; Published online first: 5 December 2017 The tumour necrosis factor (TNF) inhibitor infliximab is known to significantly improve...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2017.0604.042

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Commentary

Published on 14 February 2012

Innovator companies should focus on innovations

Abstract: Despite biopharmaceuticals having an enormous potential value for our health, they have also become a serious threat to our healthcare systems. Submitted: 22 June 2011; Revised manuscript received: 6...

Author(s): Professor Theodor Dingermann, PhD

DOI: 10.5639/gabij.2012.0101.003

8.801 views

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