Articles

Interview

Published on 12 December 2014

Amgen’s move into the biosimilars market

Abstract: Biotech giant Amgen now has a biosimilars programme that includes nine different molecules. A representative from Amgen has spoken to GaBI about the company’s venture into biosimilars. Topics included...

Author(s): GaBI Journal Editor

biosimilar, naming, uptake

DOI: 10.5639/gabij.2014.0304.048

6.649 views

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Special Report

Published on 28 June 2017

Physician associations comment on FDA’s interchangeability guidance

Abstract: Comments from physician associations on the US Food and Drug Administration’s draft guidance on interchangeability of biosimilars are presented in this paper. Various issues were discussed; this paper highlights...

Author(s): GaBI Journal Editor

biosimilar, extrapolation, interchangeability, labelling, switching, US Food and Drug Administration (FDA)

DOI: 10.5639/gabij.2017.0603.024

6.645 views

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Letters to the Editor

Published on 29 October 2013

Legislative efforts to limit prescription information sharing between patients and healthcare providers represent a serious threat to the health and safety of the American nation

Abstract: Legislation in support of pharmacist notification to patients and providers of substitution of an interchangeable biologic for the originator biologic was recently vetoed in California. Automatic substitution of approved...

Author(s): Janet S Wyatt, RN, PhD, FAANP

biologicals, patients, REMS

DOI: 10.5639/gabij.2013.0204.045

6.639 views

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Abstracted Scientific Content

Published on 12 December 2013

Biosimilarity of anticancer monoclonal antibodies in the clinic

The European Medicines Agency recommends the use of pharmacodynamics (PD) markers when establishing biosimilarity, but no such biomarkers are known for the clinical efficacy of bevacizumab (Avastin). For this reason,...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2014.0301.013

6.585 views

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Review Article

Published on 07 May 2024

Increasing adoption of quality-assured biosimilars to address access challenges in low- and middle-income countries

Author byline as per print journal: Pritha Paul1, PhD; Rahul Kapur2*, MBBS, PhD; Shivani Mittra3, MPharm, PhD; Nimish Shah4, JD, MBA; Gopal K Rao1, MSc; Matthew E Erick4, BS, RPh;...

affordability, biosimilars, low- and middle-income countries (LMICs), market access, non-communicable diseases, regulatory framework

DOI: 10.5639/gabij.2024.1302.008

6.500 views

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Editor's Letter

Published on 19 April 2013

Editor’s introduction to the wide range of topics in the initial issue of the second volume of GaBI Journal

We start off the second year of GaBI Journal with articles covering a wide range of issues. In Letters to the Editor, Dr Christian K Schneider discusses and expands on...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2013.0201.015

6.450 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

6.439 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

6.398 views

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Letters to the Editor

Published on 02 September 2014

Access to alternative biopharmaceuticals in low- and middle-income countries

Abstract: Alternative biopharmaceuticals could substantially improve affordability of biotherapeutics in developing countries. However, it seems that these countries need a modified regulatory pathway to guarantee timely access to these medicines....

Author(s): Professor Abdol Majid Cheraghali, PharmaD, PhD

affordability, alternative biopharmaceuticals, regulation

DOI: 10.5639/gabij.2014.0304.038

6.371 views

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Letters to the Editor

Published on 27 November 2013

Critical immunogenicity differences will be obscured by a common INN for biosimilars

Abstract: Information about variable immunogenicity arising from formulation differences between competing biosimilars is critical for informed judgments by prescribing physicians. Use of a common INN for biosimilars will obfuscate such...

Author(s): Edward T Maggio, PhD

immunogenicity, INN, neoantigen, neutralizing antibodies, oxidative damage, polysorbate, protein aggregation

DOI: 10.5639/gabij.2013.0204.046

6.363 views

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Meeting Report

Published on 02 March 2023

Non-medical switching of biologicals/biosimilars: Canada, Europe and the US – a webinar report

Author byline as per print journal: Michael S Reilly, Esq; Gail Attara; Ralph D McKibbin, MD, FACP, FACG, AGAF; Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP Introduction: Biosimilars are...

biologicals, biosimilars, forced-switching, interchangeable biosimilar, non-medical switching

DOI: 10.5639/gabij.2023.1201.006

6.335 views

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Meeting Report

Published on 25 March 2015

First Latin American educational workshop on similar biotherapeutic products, Mexico City, Mexico, 20 January 2015

Introduction: Similar Biotherapeutic Products (SBPs or biosimilars) comprise a rapidly expanding area of therapeutics worldwide. However, best practices for their regulation are lacking in many Latin American countries. Methods: The...

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

biologicals, biosimilars, follow-on drugs, Latin America, Mexico, regulatory practice

DOI: 10.5639/gabij.2015.0403.031

6.295 views

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