Articles

Rhythm

Published on 15 February 2012

Clinical biosimilar data should be accessible to all Calls are growing for biosimilar manufacturers to publish their data in the public domain, particularly when developing versions of monoclonal antibodies that are associated...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2012.0101.012

9.099 views

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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MS, FASHP; Michael S Reilly, Esq Introduction: To date, the US Food and Drug Administration (FDA) has offered only draft guidance...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

9.076 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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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

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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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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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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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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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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

8.836 views

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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

8.812 views

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