Articles

Perspective

Published on 29 June 2016

Importance of manufacturing consistency of the glycosylated monoclonal antibody adalimumab (Humira®) and potential impact on the clinical use of biosimilars

Author byline as per print journal: Professor Paul J Declerck, PhD; Paul W Tebbey, PhD Abstract: The clinical performance of biological therapies is affected by their manufacturing processes. The advent...

Author(s): Paul W Tebbey, PhD, Professor Paul J Declerck, PhD

adalimumab, biosimilar pharmaceuticals, consistency, glycosylation, immunogenicity, manufacturing

DOI: 10.5639/gabij.2016.0502.018

17.680 views

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Perspective

Published on 27 April 2016

New monoclonal antibody biosimilars approved in 2015 in Latin America: position statement of the Latin American Forum on Biosimilars on biosimilarity, interchangeability and extrapolation of indications

Author byline as per print journal: Valderílio Feijó Azevedo1,2, Alejandra Babini3,4, Fabio Vieira Teixeira5,6, Igor Age Kos1,2, Pablo Matar7 Introduction: The Latin American Forum on Biosimilars (FLAB) is an annual...

Author(s): Alejandra Babini, Associate Professor Valderilio Feijó Azevedo, MD, PhD, MSc, Igor Age Kos, Pablo Matar, PhD, Professor Fabio V Teixeira, MSc, MD, PhD

biosimilarity, extrapolation, infliximab, interchangeability, monoclonal antibodies, rituximab

DOI: 10.5639/gabij.2016.0502.017

12.386 views

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Legal

Published on 08 March 2016

Biosimilars patent litigation in Canada and Japan: a comparative strategic overview and EU and US update

Abstract: Biosimilars are highly similar versions of reference biological products, some with the potential to be deemed ‘interchangeable’ by medicines regulatory bodies, such as the US Food and Drug Administration....

Author(s): Brian J Malkin, Esq, Esq

351(k), Federal Circuit, interchangeable biosimilar, Japan Pharmaceuticals and Medical Devices Agency (PMDA), patent litigation linkage, subsequent entry biologics (SEBs)

DOI: 10.5639/gabij.2016.0502.016

9.076 views

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Review Article

Published on 04 May 2016

Assessment of the interchangeability between generics

Author byline as per print journal: Luther Gwaza1,2, BPharm, MPhil; John Gordon3, PhD; Henrike Potthast4, PhD; Marc Maliepaard5, PhD; Jan Welink5, Hubert Leufkens1,5, PhD; Matthias Stahl6, MD; Alfredo García-Arieta7, PhD...

Author(s): Alfredo García Arieta, PhD, Henrike Potthast, PhD, Hubert Leufkens, PhD, Jan Welink, John Gordon, PhD, Luther Gwaza, BPharm, MPhil, Marc Maliepaard, PhD, Matthias Stahl, MD

adjusted indirect comparisons, bioequivalence, drug switching, generic medicines, interchangeability, prequalification

DOI: 10.5639/gabij.2016.0502.015

12.571 views

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Pharma News

Published on 27 June 2016

The anti-TNF biosimilar CT-P13 had comparable efficacy to infliximab in rheumatoid arthritis over one year

Submitted: 24 May 2016; Revised: 8 June 2016; Accepted: 10 June 2016; Published online first: 24 June 2016 The introduction of biologicals has revolutionized the treatment of immune-mediated diseases such...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0502.024

7.246 views

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Pharma News

Published on 27 June 2016

Switching from the infliximab reference product to CT-P13 in patients with rheumatoid arthritis or ankylosing spondylitis: results of the PLANETAS and PLANETRA extension studies

Submitted: 24 May 2016; Revised: 8 June 2016; Accepted: 10 June 2016; Published online first: 24 June 2016 CT-P13, also known by its brand names Remsima or Inflectra, is a...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0502.023

13.355 views

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Editorial

Published on 29 June 2016

Adjusted indirect comparisons between generics – bioequivalence and interchangeability

Abstract: Adjusted indirect comparisons are valuable to establish the bioequivalence and thereby the interchangeability between generic drug products. Limitations should be observed especially when several generics of a drug are...

Author(s): Professor Laszlo Endrenyi, PhD, DSc, Professor László Tóthfalusi, MSc, PhD

adjusted indirect comparisons, bioequivalence, generic drugs, generic medicines, interchangeability, switchability

DOI: 10.5639/gabij.2016.0502.014

7.678 views

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Editor's Letter

Published on 04 July 2016

What to look forward to in GaBI Journal, 2016, Issue 2

This second issue of 2016 includes manuscripts that cover a number of important issues of interest to GaBI Journal including methods used to assess bioequivalence and decide on interchangeability, patient and...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2016.0502.013

3.970 views

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Special Report

Published on 07 April 2016

Complexity in the making: non-biological complex drugs (NBCDs) and the pharmacopoeias

Abstract: Pharmacopoeias, as standard references for pharmaceutical drug specifi cations and reference standards in the form of monographs, play a pivotal role to assure drug quality and safety. With emphasis...

Author(s): Professor Gerrit Borchard, PharmD, PhD

drug quality, ICH, non-biological complex drug (NBCD), Ph. Eur., pharmacopoeia, USP

DOI: 10.5639/gabij.2016.0501.009

18.184 views

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Abstracted Scientific Content

Published on 18 April 2016

The case for reforming drug naming

Submitted: 29 February 2016; Revised: 15 March 2016; Accepted: 16 March 2016; Published online first: 29 March 2016 Use of brand name drugs over generic equivalents after expiration of exclusivity...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0501.012

4.984 views

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Abstracted Scientific Content

Published on 16 December 2015

Promoting a competitive generics market in the US

Submitted: 15 December 2015; Revised: 15 December 2015; Accepted: 15 December 2015; Published online first: 16 December 2015 As a result of recent price increases and shortages, the US generics...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0501.011

5.866 views

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