Articles

Review Article

Published on 03 December 2021

Biotechnological therapies and biosimilars for COVID-19: scarcities, poor regulation, and pharmaceutical black market: a case analysis in Ecuador

Author byline as per print journal: Esteban Ortiz-Prado1, MD, MSc, MPH, PhD(c); Enrique Teran2, MD, PhD; Raul Patricio Fernandez Naranjo1, MSc; Doménica Cevallos-Robalino1, MD; Eduardo Vasconez1, MD; Alex Lister3, MPH At...

biosimilars, black market, COVID-19 pandemic, interleukins, tocilizumab

DOI: 10.5639/gabij.2021.1004.023

9.969 views

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Review Article

Published on 29 September 2021

The European framework for intellectual property rights for biological medicines

Author byline as per print journal: Josette Sciberras, MBA, MA Bioethics, BPharm (Hons); Raymond Zammit, SThD; Patricia Vella Bonanno, PhD Introduction: The Pharmaceutical Strategy for Europe (2020) proposes actions related to...

biological medicines, European intellectual property rights, market access, pricing, R & D

DOI: 10.5639/gabij.2021.1004.022

10.501 views

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Original Research

Published on 29 September 2021

Extended stability of the trastuzumab biosimilar ABP 980 (KANJINTI™) in polyolefin bags and elastomeric devices

Author byline as per print journal: Lyndsay Davies1, PhD; Katie Milligan1, BSc; Mark Corris1, BSc; Ian Clarke1; Paul Dwyer1, MSc; Sarah Elizabeth Lee2, PhD; Jolene Teraoka3, BSc; Jill Crouse-Zeineddini3, PhD; Jane...

biosimilar, elastomeric device, KANJINTI® ABP 980, stability, trastuzumab

DOI: 10.5639/gabij.2021.1004.021

8.228 views

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Editor's Letter

Published on 29 September 2021

Latest features in GaBI Journal, 2021, Issue 3

This issue of GaBI Journal contains articles dealing with some very practical issues related to the evaluation, describing, and use of generic and biosimilar products. These issues include the uncertainty...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2021.1003.012

3.377 views

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Published on 29 September 2021

2021/3 GaBI Journal Table of Contents

Contents Editor’s Letter Latest features in GaBI Journal, 2021, Issue 3 Original Research Pharmacokinetics and bioequivalence of generic etoricoxib in healthy volunteers Reasons for patients’ generic drug switching at the...

1.598 views

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Research News

Published on 10 September 2021

Biosimilar epoetin for cancer and chemotherapy-induced anaemia in the US

Biosimilars are biological drug products that are highly similar to reference products in analytic features, pharmacokinetics and pharmacodynamics, immunogenicity, safety and efficacy. Biosimilar epoetin received US Food and Drug Administration...

DOI: 10.5639/gabij.2021.1003.015

2.388 views

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Pilot Study

Published on 30 August 2021

Use of biologicals in dermatology – following the agreed path or going off-piste? A brief report

Author byline as per print journal: Michael Wilcock, MPhil; Andrew Pothecary, MSc Introduction: Biological medicines are used to treat a range of conditions according to National Institute for Health and...

biologicals, biosimilars, dermatology, psoriasis

DOI: 10.5639/gabij.2021.1003.018

5.828 views

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Original Research

Published on 30 August 2021

Pharmacokinetics and bioequivalence of generic etoricoxib in healthy volunteers

Author byline as per print journal: Nishalini Harikrishnan1, BSc; Ka-Liong Tan2, DPhil; Kar Ming Yee3, BPharm; Alia Shaari Ahmad Shukri1, MSc; Nalla Ramana Reddy4, MBBS; Chuei Wuei Leong3, PhD Introduction/Study...

bioequivalence, COX-2 inhibitor, etoricoxib, generics

DOI: 10.5639/gabij.2021.1003.013

8.372 views

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Abstracted Scientific Content

Published on 22 June 2021

An IPRP survey of the regulatory requirements for the waiver of in vivo bioequivalence studies of generic medicinal products in certain dosage forms

Submitted: 14 May 2021; Revised: 14 May 2021; Accepted: 3 June 2021; Published online first: 10 June 2021 Medicines regulatory authorities aim to address rising healthcare costs and promote access...

Author(s): Alfredo García Arieta, PhD, Clare Rodrigues

DOI: 10.5639/gabij.2021.1003.019

3.534 views

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Review Article

Published on 22 June 2021

Microbiological, scientific and regulatory perspectives of hand sanitizers

Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc; Tan Ying Ting, BSc Pharm (Hons); Associate Professor Chan Lai Wah, BSc Pharm (Hons), PhD...

Effectiveness, hand sanitizers, myths, regulatory framework, safety, standards

DOI: 10.5639/gabij.2021.1003.017

8.611 views

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Published on 22 June 2021

2021/2 GaBI Journal Table of Contents

Contents Editor’s Letter What to look forward to in GaBI Journal, 2021, Issue 2 Original Research Summative usability evaluation of the YLB113 etanercept biosimilar autoinjector via simulation Biosimilars in Saudi...

1.622 views

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