Articles

Editor's Letter

Published on 16 September 2015

Latest features in GaBI Journal, 2015, Issue 3

This issue of the journal contains a number of manuscripts that discuss proposals to simplify the evaluation of, and therefore decrease the cost of developing, follow-on biological products. These controversial...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2015.0403.022

3.648 views

Read more →

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

13.781 views

Read more →

Regulatory

Published on 28 May 2015

Update on US state legislation on biosimilars substitution

Abstract: Since the biosimilars pathway was introduced, many US states have been considering, or have introduced, legislation to allow for substitution of biosimilars deemed interchangeable. This paper gives an update...

Author(s): GaBI Journal Editor

biologicals, biosimilars, legislation, notification, substitution

DOI: 10.5639/gabij.2015.0402.020

9.304 views

Read more →

Perspective

Published on 28 May 2015

Norway, biosimilars in different funding systems. What works?

Abstract: Biosimilars can substitute treatment with expensive biological drugs and release money to treat more patients. Experience from Norway shows how this can be done with and without success. Submitted:...

Author(s): Asbjørn Mack, MD

biosimilars, discounts, market penetration, tender

DOI: 10.5639/gabij.2015.0402.018

18.806 views

Read more →

Original Research

Published on 17 April 2015

Product naming, pricing, and market uptake of biosimilars

Abstract: With a number of patents on biological medicines soon to expire in the US, multiple stakeholders – from policymakers to manufacturers to payers – have been debating the structure...

Author(s): Jacqueline Vanderpuye-Orgle, MSc, PhD, Joseph P Fuhr, PhD, Amitabh Chandra, PhD, John Romley, PhD, Tiffany Shih, PhD, Suepattra G May, MPH, PhD

biosimilar, market uptake, nomenclature, regulatory, specialty pharmaceuticals

DOI: 10.5639/gabij.2015.0402.015

22.176 views

Read more →

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: Ljiljana Sović Brkičić, MPharm; Brian Godman, BSc, PhD; Martina Bogut, BSc; Miron Sršen, 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 Sović Brkičić, MPharm, Martina Bogut, BSc, Miron Sršen, MD, Tonko Tabain, MD, Winnie de Bruyn, BSc

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

DOI: 10.5639/gabij.2015.0402.017

36.449 views

Read more →

Original Research

Published on 16 December 2014

Differences in pharmacokinetic behaviour of branded enoxaparin and a US generic version in a non-human primate model

Author byline as per print journal: Professor Walter P Jeske, PhD; Jeanine M Walenga, PhD; Nicolas Simon, MD, PhD; Debra Hoppensteadt, PhD; Josephine Cunanan, MD; Vicki Escalante, BS; Jawed Fareed, PhD;...

Author(s): Debra Hoppensteadt, PhD, Jawed Fareed, PhD, Jeanine M Walenga, PhD, Josephine Cunanan, MD, Mamdouh Bakhos, MD, Nicolas Simon, MD, PhD, Vicki Escalante, BS, Professor Walter P Jeske, PhD

anticoagulation, generics, heparins, pharmacodynamics, pharmacokinetics, population

DOI: 10.5639/gabij.2015.0402.016

32.254 views

Read more →

Published on 26 March 2015

Online biosimilars resource for patients across Latin America

Submitted: 6 March 2015; Revised: 9 March 2015; Accepted: 10 March 2015; Published online first: 23 March 2015 A new online resource on biological and biosimilar medicines in Latin America...

Author(s): Ian Ford

DOI: 10.5639/gabij.2015.0402.021

5.207 views

Read more →

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

21.125 views

Read more →

Editor's Letter

Published on 15 June 2015

What to look forward to in GaBI Journal, 2015, Issue 2

This entire issue of the GaBI Journal could be titled ‘World News’ since it contains manuscripts describing global generics and biosimilar activities. The Commentary by Leng et al. describes regulatory...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2015.0402.013

3.541 views

Read more →

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

5.797 views

Read more →