Articles

Regulatory

Published on 26 October 2016

Regulatory Science Ireland: bridging the information gap on biosimilar medicines

Author byline as per print journal: Joan O’Callaghan, BSc Pharm; Sean Barry, PhD; Una Moore, PhD; Margaret Bermingham, PhD; J Michael Morris, PhD; Frank Hallinan, PhD; Brendan T Griffin, PhD Abstract: Regulatory...

Author(s): Brendan T Griffin, PhD, Frank Hallinan, PhD, J Michael Morris, PhD, Joan O’Callaghan, BSc Pharm, Margaret Bermingham, PhD, Sean Barry, PhD, Una Moore, PhD

biological medicines, biosimilar, Health Products Regulatory Authority, regulatory science, Regulatory Science Ireland

DOI: 10.5639/gabij.2016.0504.043

9.418 views

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Review Article

Published on 26 October 2016

Cost-minimization analysis of generic equivalents (bortezomib, decitabine and capecitabine) in comparison to the originator brand medicines in Colombia

Author byline as per print journal: Shyam Akku, MD; Amit Garg, MD; Suhas Khandarkar, MPharm Introduction: Majority of the Colombian population has become health insured leading to improved healthcare access in...

Author(s): Amit Garg, MD, Shyam Akku, MD, Suhas Khandarkar, MPharm

anticancer drugs, cost-minimization, generics, pharmacoeconomics

DOI: 10.5639/gabij.2016.0504.042

15.938 views

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Original Research

Published on 27 July 2016

Assessment of active pharmaceutical ingredients in drug registration procedures in Pakistan: implications for the future

Author byline as per print journal: Babar Khan, BPharm, MPH, PhD; Brian Godman, BSc, PhD; Ayesha Babar, BPharm, MPhil; Shahzad Hussain, BPharm, MPhil; Sidra Mahmood, PharmD, MSc; Tahir Aqeel, BPharm, MPhil...

Author(s): Ayesha Babar, BPharm, MPhil, Babar Khan, BPharm, MPH, PhD, Brian Godman, BSc, PhD, Shahzad Hussain, BPharm, MPhil, Sidra Mahmood, PharmD, MSc, Tahir Aqeel, BPharm, MPhil

API (active pharmaceutical ingredient), Drugs Regulatory Authority, generics, ibuprofen, Pakistan

DOI: 10.5639/gabij.2016.0504.041

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MS, FASHP; Michael S Reilly, Esq Introduction: To date, the US Food and Drug Administration (FDA) has offered only draft guidance...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

9.149 views

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Editorial

Published on 26 October 2016

Physicians, Hippocrates and biosimilars: applying ancient principles in a modern society

Abstract: Physicians are pondering the clinical use of biosimilars. A reliance on clinical trials is deeply rooted in the modern healthcare system, whereas comparability and totality of evidence remain unknown...

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

biosimilars, NOR-SWITCH, totality of evidence

DOI: 10.5639/gabij.2016.0504.039

6.425 views

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Editor's Letter

Published on 16 December 2016

Fourth and final issue of GaBI Journal’s fifth volume

This fourth and final GaBI Journal issue of 2016 begins with the paper by Adjunct Professor Pekka Kurki about ‘applying ancient principles in a modern society’ in which he discusses...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2016.0504.038

3.820 views

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Special Report

Published on 21 September 2016

US FDA proposals for naming of biologicals and labelling of biosimilars

Abstract: There is considerable concern and debate over the naming of biologicals and labelling of biosimilars. To ensure that patients receive the safest and most effective treatment, it is paramount...

Author(s): GaBI Journal Editor

biologicals, biosimilars, labelling, naming, nomenclature, regulation

DOI: 10.5639/gabij.2016.0503.036

9.505 views

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Meeting Report

Published on 03 October 2016

Demonstrating interchangeability and biosimilarity for US biosimilars

Abstract: The US Food and Drug Administration (FDA) outlines its approach to biosimilarity and interchangeability at the 2016 Generic Pharmaceutical Association Biosimilars Council Conference. Topics covered include the FDA definition...

Author(s): GaBI Journal Editor

biologicals, biosimilar, biosimilarity, interchangeability, regulation

DOI: 10.5639/gabij.2016.0503.035

4.523 views

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Meeting Report

Published on 21 September 2016

First Turkish interactive workshop on regulation and approval of similar biotherapeutic products/biosimilars, 2–3 March 2016, Ankara, Turkey

Abstract: This paper discusses the findings and summary of items covered in the First Turkish interactive workshop on regulation and approval of similar biotherapeutic products/biosimilars, in which structure–function was highlighted...

Author(s): Professor Philip D Walson, MD, Robin Thorpe, PhD, FRCPath

glycosylation, immunogenicity, potency, receptor binding, serum half-life, sialic acid

DOI: 10.5639/gabij.2016.0503.034

8.501 views

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Perspective

Published on 24 October 2016

Biosimilars in Italy: a gastroenterologist’s view

Author byline as per print journal: Vito Annese, MD; Tommaso Gabbani, MD; Antonio Luca Annese, MD Abstract: The introduction of biological therapy has revolutionized the paradigm of treatment in the...

Author(s): Antonio Luca Annese, MD, Tommaso Gabbani, MD, Vito Annese, MD

adalimumab, biosimilar, Crohn’s disease (CD), inflammatory bowel disease (IBD), switching, ulcerative colitis (UC)

DOI: 10.5639/gabij.2016.0503.033

7.516 views

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