Articles

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

15.327 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

15.131 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

16.089 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

7.646 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

9.372 views

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Commentary

Published on 07 April 2016

Low-cost generic drug programs in the US: implications for payers and researchers

Abstract: Low-cost generic drug programs (LCGPs) provide affordable generics in the US. However, LCGPs have implications for managed care organizations and researchers relying on claims data. Submitted: 7 March 2016;...

Author(s): Joshua D Brown, PharmD, MS

generic medicines, low-cost generic drug programs, quality assessment, United States healthcare system

DOI: 10.5639/gabij.2016.0501.003

4.783 views

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Commentary

Published on 18 April 2016

Waiver of consent for retrospective chart review studies

Abstract: The importance of obtaining IRB/EC consent for waiver of consent before embarking on retrospective chart review studies was highlighted using the recent case of a manuscript submitted to GaBI...

Author(s): Professor Philip D Walson, MD

chart review, consent, retrospective, waiver

DOI: 10.5639/gabij.2016.0501.004

16.270 views

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Editor's Letter

Published on 04 May 2016

Editor’s introduction to the initial issue of the fifth volume of GaBI Journal

This issue begins with a Letter to the Editor by Professor Fabio V Teixeira from the Brazilian Inflammatory Bowel Disease (IBD) Society that deals basically with the issue of extrapolation...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2016.0501.001

3.190 views

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Readers' Comments

Published on 14 December 2015

Pro-generics policies and the backlog in medicines registration in South Africa: implications for access to essential and affordable medicines Comment by Ernest Schay, Bayer Thank you for this very interesting...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2015.0404.044

3.485 views

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Meeting Report

Published on 11 December 2015

First MENA educational workshop on regulation and approval of similar biotherapeutic products/biosimilars, Dubai, United Arab Emirates, 1 September 2015

Introduction: Similar biotherapeutic products (SBPs or biosimilars) include a rapidly expanding number of therapeutic products worldwide. However, agreement about the best practices for their regulation are lacking in many countries...

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

biologicals, biosimilars, follow-on drugs, MENA (Middle East and North Africa), regulatory practice

DOI: 10.5639/gabij.2015.0404.039

13.832 views

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Special Report

Published on 11 December 2015

Patent expiry dates for best-selling biologicals

Abstract: Biosimilars have been approved in Europe since 2006. With patents on originator biologicals expiring and ever-tightening healthcare budgets biosimilars are likely to take an increasing share of the biologicals...

Author(s): GaBI Journal Editor

biological, biosimilar, patent

DOI: 10.5639/gabij.2015.0404.040

21.626 views

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Special Report

Published on 11 December 2015

Supporting biosimilarity and extrapolation

Abstract: With many biosimilars being approved around the world, there is an urgent need for clear guidelines on establishing biosimilarity and on approving subsequent extrapolation. The balance between clinical studies...

Author(s): GaBI Journal Editor

analytics, biosimilarity, clinical studies, extrapolation

DOI: 10.5639/gabij.2015.0404.041

17.463 views

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