Articles

Meeting Report

Published on 19 January 2018

Quality assessment of biosimilars in Colombia – reducing knowledge gaps

Abstract: Biosimilar medicines are having a global effect, and as such regulatory agencies worldwide are assessing how to respond to them. Here, two events held by GaBI for the Colombian...

Author(s): Elaine Gray, PhD, Paul Matejtschuk, PhD, CChem, Robin Thorpe, PhD, FRCPath

biologicals, biosimilars, Colombia, quality assessment, regulatory

DOI: 10.5639/gabij.2018.0702.017

7.209 views

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Regulatory

Published on 14 June 2018

Biosimilar regulation and approval in Jordan

Author byline as per print journal: Rana Musa Ali Al-ali “Malkawi”, MSc; Wesal Salem Al Haqaish, BPharm; Hayel Obeidat, MD Abstract: The regulatory oversight of medicinal products in Jordan is...

Author(s): Hayel Obeidat, MD, Rana Musa Ali Al-ali “Malkawi”, MSc, Wesal Salem Al-haqaish, BPharm

biological, biosimilar, EMA, INN, Jordan FDA, regulation

DOI: 10.5639/gabij.2018.0702.016

11.375 views

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Regulatory

Published on 06 April 2018

Regulation of copy biologicals in China

Abstract: The first draft guidelines for copy biologicals were introduced in China back in 2014. The Technical Guideline was then updated and finalized in 2015. In this paper, how the...

Author(s): GaBI Journal Editor

biological, China, copy biological, regulation

DOI: 10.5639/gabij.2018.0702.015

7.296 views

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Perspective

Published on 20 January 2014

How to realize the potential of off-patent biologicals and biosimilars in Europe? Guidance to policymakers

Author byline as per print journal: Steven Simoens, PhD; Claude Le Pen, PhD; Niels Boone, PharmD; Ferdinand Breedveld, MD, PhD; Antonella Celano; Antonio Llombart-Cussac, MD, PhD; Frank Jorgensen, MPharm, MM;...

Author(s): Ad A van Bodegraven, MD, PhD, Andras Süle, PhD, Antonella Celano, Antonio Llombart Cussac, MD, PhD, Frank Jorgensen, MPharm, MM, Jo De Cock, Niels Boone, PharmD, Professor Claude Le Pen, PhD, Professor Ferdinand Breedveld, MD, PhD, Rene Westhovens, MD, PhD, Steven Simoens, MSc, PhD

biologicals, biosimilars, competition, Europe, policy, sustainability

DOI: 10.5639/gabij.2018.0702.014

17.643 views

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Review Article

Published on 04 April 2018

Protein heterogeneity and the immunogenicity of biotherapeutics

Abstract: High resolution analytical techniques reveal structural micro-heterogeneity within endogenous proteins, however, they are ‘seen’ as ‘self’ molecules by the immune system and immunological tolerance is established. In contrast the...

Author(s): Professor Roy Jefferis, PhD, DSc, MRCP, FRCPath

allotypes, erythropoietin, human IgG, idiotypes, immunogenicity, polymorphisms, post-translational modifications, structural heterogeneity

DOI: 10.5639/gabij.2018.0702.013

17.000 views

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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

8.940 views

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Commentary

Published on 26 October 2016

Potential changes to the FDA approach to biosimilars have a global impact

Abstract: The Opinion article of Niazi urges the US Food and Drug Administration (FDA) to make adjustments to its guidance on biosimilar development. This article comments on some of the...

Author(s): Adjunct Professor Pekka Kurki, MD, PhD

automatic substitution, FDA guidelines, global reference product, information, interchangeability, regulatory harmonization

DOI: 10.5639/gabij.2018.0702.011

7.779 views

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Editor's Letter

Published on 27 August 2018

What to look forward to in GaBI Journal, 2018, Issue 2

The second issue of the 2018 GaBI Journal volume is being published at a time of increasing uncertainty concerning trade, tariffs, regulations as well as international and even inter-ally co-operation....

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2018.0702.010

3.109 views

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Abstracted Scientific Content

Published on 02 February 2018

Barriers to generics policy reform: a US case study

Submitted: 29 December 2017; Revised: 5 January 2018; Accepted: 12 January 2018; Published online first: 19 January 2018 A recent comparison of generic drug markets [1] explores the history of...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2018.0701.009

4.861 views

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Pharma News

Published on 06 September 2017

Top developments in biosimilars during 2017

Submitted: 30 January 2018; Revised: 8 February 2018; Accepted: 12 February 2018; Published online first: 26 February 2018 The past year has once again been a busy one for the...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2018.0701.008

11.552 views

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Special Report

Published on 19 January 2018

Patent expiry dates for biologicals: 2017 update

Abstract: Although small molecule drugs still dominate the global pharmaceutical market in terms of numbers, biologicals are making a significant dent. However, the high cost of biologicals is putting increasing...

Author(s): GaBI Journal Editor

biological, biosimilar, patent

DOI: 10.5639/gabij.2018.0701.007

33.450 views

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Regulatory

Published on 17 January 2018

Regulations for biotherapeutics approval in Colombia

Author byline as per print journal: Johanna Andrea García Cortes, MSc; Francisco Javier Sierra Esteban, MSc Abstract: Colombia is in the process of implementing legislation to allow for the approval...

Author(s): Francisco Javier Sierra Esteban, MSc, Johanna Andrea García Cortes, MSc

abbreviated comparability, biotherapeutics approval, Colombia, INVIMA

DOI: 10.5639/gabij.2018.0701.006

46.287 views

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