Articles

Commentary

Published on 24 March 2015

Pro-generics policies and the backlog in medicines registration in South Africa: implications for access to essential and affordable medicines

Abstract: The backlog in medicines registration in South Africa is a result of the implementation of pro-generics policies without strengthening the regulator to handle the substantial increase in registration applications...

Author(s): Allyson M Pollock, MBChB, FFPH, MRCP (Ed), MRCGP, Henry MJ Leng, PhD, David Sanders, MRCP

access to medicines, generic medicines registration, registration backlog, South Africa

DOI: 10.5639/gabij.2015.0402.014

21.444 views

Read more โ†’

Original Research

Published on 24 March 2015

Pharmaceutical pricing in Croatia: a comparison of ordinances in 2013 versus 2009 and their potential savings to provide future guidance

Author byline as per print journal:ย Ljiljana Soviฤ‡ Brkiฤiฤ‡, MPharm; Brian Godman, BSc, PhD; Martina Bogut, BSc; Miron Srลกen, MD; Hye-Young Kwon, BPharm, MPH, PhD; Winnie de Bruyn, BSc; Tonko Tabain,...

Author(s): Brian Godman, BSc, PhD, Hye-Young Kwon, BPharm, MPH, PhD, Ljiljana Soviฤ‡ Brkiฤiฤ‡, MPharm, Martina Bogut, BSc, Miron Srลกen, MD, Tonko Tabain, MD, Winnie de Bruyn, BSc

biosimilars, Croatia, generics, pharmaceuticals, reference pricing system, reforms

DOI: 10.5639/gabij.2015.0402.017

36.796 views

Read more โ†’

Regulatory

Published on 20 March 2015

Korean regulations for biosimilars

Abstract: Regulations for biosimilars in the Republic of Korea have been in place since 2009. Since then, the country has also put in place specific guidelines and approved four biosimilars....

Author(s): Jeewon Joung, PhD

biosimilar, guidelines, regulation, Republic of Korea

DOI: 10.5639/gabij.2015.0402.019

14.032 views

Read more โ†’

Meeting Report

Published on 12 March 2015

2014 World Transplant Congress, San Francisco, California, USA, 26โ€“31 July 2014

This was a joint meeting of the American Society of Transplant Surgeons (ASTS), The Transplant Society (TTS) and the American Society of Transplantation (ATS). The Congress was packed with an...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2014.0304.047

3.925 views

Read more โ†’

Pharma News

Published on 06 March 2015

Top developments in biosimilars during 2014

Submitted: 10 February 2015; Revised: 24 February 2015; Accepted: 25 February 2015; Published online first: 6 March 2015 The past year has once again been a busy one for the...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2015.0401.010

11.748 views

Read more โ†’

Abstracted Scientific Content

Published on 20 February 2015

Generics and off-patent biologicals for cancer treatment in developing countries

Submitted: 11 February 2015; Revised: 14 February 2015; Accepted: 15 February 2015; Published online first: 20 February 2015 Cancer represents a significant, and growing, burden on healthcare systems around the...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2015.0401.012

5.853 views

Read more โ†’

Regulatory

Published on 06 February 2015

Health Canadaโ€™s perspective on the clinical development of biosimilars and related scientific and regulatory challenges

Abstract: Biologicals have offered a new avenue for targeting therapy to treat life-threatening and chronic diseases. The recent or pending patent expirations of many successful biologicals have permitted the marketing...

Author(s): Agnes V Klein, MD, DPH, Jian Wang, MD, PhD, Ally Pen, PhD

biologicals, biosimilars, clinical trials, extrapolation, immunogenicity, regulatory

DOI: 10.5639/gabij.2015.0401.009

13.130 views

Read more โ†’

Published on 30 January 2015

Generics authorization โ€“ groundbreaking regulatory approach to closer international cooperation on the rise โ€“ IGDRP

Submitted: 24 January 2015; Revised: not applicable; Accepted: 27 January 2015; Published online first: 30 January 2015 The โ€˜International Generic Drug Regulators Pilotโ€™ (IGDRP) seems to be a true model...

Author(s): Christoph Baumgรคrtel, MD, MSc, DI Dr Katharina Gazda-Pleban

DOI: 10.5639/gabij.2015.0401.011

7.445 views

Read more โ†’

Published on 29 January 2015

2014/4 GaBI Journal Table of Contents

Contents Editorโ€™s Letter Fourth and final issue of GaBI Journalโ€™s third volume Editorial Availability and procurement of generics in hospitals among medium-sized European countries Letters to the Editor Access to...

3.479 views

Read more โ†’

Editor's Letter

Published on 17 December 2014

Fourth and final issue of GaBI Journalโ€™s third volume

The interest in the development, regulatory approval, use, and post-marketing surveillance of generic and biosimilar pharmaceutical products continues to increase; as illustrated by the tremendous number of views (over 1,028,324...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2014.0304.036

3.821 views

Read more โ†’