Articles

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

13.311 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

7.627 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

3.957 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

18.046 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

4.962 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

5.810 views

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Regulatory

Published on 09 February 2016

Pricing of biosimilars in Saudi Arabia

Author byline as per print journal: Ali M Alhomaidan, PhD; Ibrahim A Aljuffali, MSc, PhD; Fahad S Alnutaifi, MHEcon, MPH; Nasseruddeen A AL-Howaimel, MSc Abstract: Innovation in the pharmaceutical industry...

Author(s): Ali M Alhomaidan, PhD, Fahad S Alnutaifi, MHEcon, MPH, Ibrahim A Aljuffali, MSc,PhD, Nasseruddeen A AL-Howaimel, MSc

biosimilar, prices, Saudi Arabia

DOI: 10.5639/gabij.2016.0501.007

15.122 views

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Review Article

Published on 20 November 2015

Life begins at forty – hybridomas: ageing technology holds promise for future drug discoveries

Abstract: Hybridomas were developed in 1975 as a stable platform for creating monoclonal antibodies (mAbs). Over the past 40 years, hybridomas have been a leading platform for creating mAbs, yet...

Author(s): Tim Steele, BS

hybridomas, microfluidics, monoclonal antibodies

DOI: 10.5639/gabij.2016.0501.006

14.955 views

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Original Research

Published on 09 February 2016

Views of physicians and patients with chronic conditions on generic medicines in Greece after the introduction of measures to promote their consumption: findings from a qualitative study

Author byline as per print journal: Eleftheria Karampli, MSc; Estathia Triga, MSc; Vasiliki Tsiantou, MSc; Kostas Athanasakis, PhD; John Kyriopoulos, PhD Introduction/Study objectives: Generic medicines uptake is widely acknowledged as...

Author(s): Eleftheria Karampli, MSc, Estathia Triga, MSc, John Kyriopoulos, PhD, Kostas Athanasakis, PhD, Vasiliki Tsiantou, MSc

generics, medicines consumption, patients, pharmaceutical policy, physicians, prescribing

DOI: 10.5639/gabij.2016.0501.005

16.037 views

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Pharma News

Published on 15 March 2016

Top developments in biosimilars during 2015

Submitted: 14 January 2016; Revised: 26 January 2016; Accepted: 27 January 2016; Published online first: 9 February 2016 Once again the biosimilars industry has had a busy year [1]. Perhaps...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0501.010

7.596 views

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Letters to the Editor

Published on 09 February 2016

First biosimilar of infliximab approved in Brazil: response from the Brazilian IBD society

Abstract: CT-P13 was the first infliximab biosimilar approved in Brazil. Approval was granted for all indications of the innovator. Despite similar efficacy and safety, vigilance remains essential. Submitted: 4 January...

Author(s): Professor Fabio V Teixeira, MSc, MD, PhD

biosimilar, CT-P13, inflammatory bowel disease (IBD), infliximab

DOI: 10.5639/gabij.2016.0501.002

9.278 views

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