Articles

Letters to the Editor

Published on 26 October 2016

Pricing strategies for pharmaceuticals in developing countries: what options do we have?

Abstract: Effective pharmaceutical pricing policies in developing countries are important to ensure accessibility and affordability of essential medicines for the people. Submitted: 24 October 2016; Revised: 27 February 2017; Accepted:...

Author(s): Nada Moustafa Abdel Rida, MSc Candidate, Professor Mohamed Izham Mohamed Ibrahim, PhD

developing countries, external reference pricing, government strategies, medicines, pharmaceutical pricing policy, price containment

DOI: 10.5639/gabij.2017.0601.002

9.549 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

7.454 views

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Perspective

Published on 03 October 2016

Are the perspectives regarding the use of biosimilars in the setting of haematology and blood and marrow transplant changing?

Introduction: Canada is among the leading spenders in pharmaceuticals. Based on projected figures, the cost of pharmaceuticals is expected to rise by another 6–12% by 2023. Approximately CAN$4.6 billion of...

Author(s): Cherie C Severson, RN, MN, CON(C), BMTCN

biologicals, biosimilars, blood and marrow transplant, cost, haematology, subsequent entry biologics (SEBs)

DOI: 10.5639/gabij.2016.0503.032

6.363 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

4.494 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

9.451 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

8.474 views

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Review Article

Published on 22 August 2016

Current state of subsequent entry biologics (biosimilars) in Canada: a view from regulatory, reimbursement, clinician, and patient perspectives

Abstract: Biological molecules represent a significant portion of therapies utilized in Canada. Biosimilars, also known as subsequent entry biologics (SEBs) in Canada, are highly comparable versions of the originator products....

Author(s): Eric CK Siu, MSc, PhD, George Wyatt, BSc, MBA

biosimilars, CADTH, Canada, CDR, pCODR, subsequent entry biologics (SEBs)

DOI: 10.5639/gabij.2016.0503.028

18.570 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

17.152 views

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Commentary

Published on 27 July 2016

Ever-changing landscape of biosimilars in Canada; findings and implications from a global perspective

Author byline as per print journal: Brian Godman1,2,3, BSc, PhD; Eleonora Allocati4, BSc, MSc; Evelien Moorkens5, BSc, MSc Abstract: Siu et al. comprehensively assessed the rapidly changing regulation and reimbursement...

Author(s): Brian Godman, BSc, PhD, Eleonora Allocati, BSc, MSc, Evelien Moorkens, BSc, MSc

biologicals, biosimilars, Canada, policy, regulation, savings

DOI: 10.5639/gabij.2019.0803.012

8.745 views

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