Articles

Opinion

Published on 01 June 2018

Rationalizing FDA guidance on biosimilars—expediting approvals and acceptance

Abstract: Biosimilar drugs have suffered slow entrance and acceptance rates in the US market, due not only to common misperceptions among the public but also US Food and Drug Administration...

Author(s): Adjunct Professor Sarfaraz K Niazi, PhD, SI, FRSB, FPAMS, FACB

analytical similarity, biosimilars, immunogenicity testing, pharmacokinetic profiling

DOI: 10.5639/gabij.2018.0702.018

14.867 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

7.367 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

17.228 views

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Original Research

Published on 10 February 2018

Analysis of Drug Master Files registered in Japan: aiming for a stable supply of active pharmaceutical ingredients

Introduction/Study objectives: A stable supply of active pharmaceutical ingredients (APIs) is indispensable for a stable supply of finished pharmaceutical products (FPPs). API manufacturers generally register API information as a Drug...

Author(s): Maki Matsuhama, MSc, Ryosuke Kuribayashi, PhD

active pharmaceutical ingredients, Drug Master File, generic drugs, globalization, stable supply

DOI: 10.5639/gabij.2018.0701.003

15.686 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

4.941 views

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Review Article

Published on 19 January 2018

Biosimilar infliximab introduction into the gastroenterology care pathway in a large acute Irish teaching hospital: a story behind the evidence

Author byline as per print journal: Gary L O’Brien1, BPharm, MPharm; Donal Carroll2, BSc (Hon) Pharmacy; Mark Mulcahy3, BComm, MSc, PhD; Valerie Walshe4, BA, MA, PhD; Professor Garry Courtney2, MB, FRCPI;...

Author(s): Professor Garry Courtney, MB, FRCPI, Professor Stephen Byrne, BSc (Hon) Pharmacy, PhD, Gary L O’Brien, BPharm, MPharm, Donal Carroll, BSc (Hon) Pharmacy, Mark Mulcahy, BComm, MSc, PhD, Valerie Walshe, BA, MA, PhD

biologicals, evidence-based, inflammatory bowel disease (IBD), secondary care, switching

DOI: 10.5639/gabij.2018.0701.004

22.322 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

33.929 views

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Review Article

Published on 19 January 2018

The impact of religion on human embryonic stem cell regulations: comparison between the UK, Germany and the US

Author byline as per print journal: Hajaj M Alhomaidan; Ali M Alhomaidan, PhD Abstract: This paper describes the differences in human embryonic stem cell regulations in several Christian countries across...

Author(s): Ali M Alhomaidan, PhD, Hajaj M Alhomaidan

regulation, religion, stem cell

DOI: 10.5639/gabij.2018.0701.005

23.534 views

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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

7.341 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

46.514 views

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Commentary

Published on 17 January 2018

EU Member States have tools to reduce costs of bestseller biologicals but can they use them?

Abstract: Major cost savings are achievable in pharmacotherapy in the European Union since biosimilars to most best-selling biological medicinal products have been licensed. Unfortunately, the window of opportunity may be...

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

automatic substitution, biosimilars, cost savings, interchangeability, payers, prescribers

DOI: 10.5639/gabij.2018.0701.002

12.538 views

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Editor's Letter

Published on 10 January 2018

Editor’s introduction to the initial issue of the seventh volume of GaBI Journal

There are many frustrating differences between reality and what is possible in every aspect of life, including politics, economics, science and health. This issue begins with a Commentary by Adjunct...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2018.0701.001

3.036 views

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