Author byline as per print journal: Brian Godman, BSc, PhD; Michael Wilcock, MPharm; Andrew Martin, MPharm; Scott Bryson, MSc, MPH; Christoph Baumgärtel, MD; Tomasz Bochenek, MD, MPH, PhD; Winne de Bruyn, BSc; Ljiljana Sović Brkičić, MPharm; Marco D’Agata, MSc; Antra Fogele, PhD; Anna Coma Fusté, MSc; Jessica Fraeyman, PhD; Jurij Fürst, MD; Kristina Garuoliene, MD, PhD; Harald Herholz, MD,…

Author(s): Brian Godman, BSc, PhD, et al.

generics, health authorities, Lyrica, pregabalin

DOI: 10.5639/gabij.2015.0403.028

Background: Uptake of super generic or hybrid pharmaceuticals has decelerated despite their important economic potential for the generic pharmaceutical industry. The aim of switching to these product portfolios was to enable product differentiation; however, these strategies are influenced by new semantic challenges, which have hampered the promotion of value-added pharmaceuticals or super generics in recent…

Author(s): Fereshteh Barei, PhD, Malcolm Ross

505(b)(2) approvals, generics, improved therapeutics, innovation, new therapeutics entities, super generics

DOI: 10.5639/gabij.2015.0401.007

Editor's Letter

Published on 26 March 2015

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

This first 2015 GaBI Journal issue (fourth volume of the journal) is being published soon after the first US biosimilar approval and it contains a number of articles that illustrate how the development, marketing and acceptance of biosimilars differ globally including in North and South America and the Persian Gulf States. An Editorial entitled Biosimilars:…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2015.0401.001

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 – created for patients, the organizations who represent them and those who want to understand more about how these issues affect patients in the region…

Author(s): Ian Ford

DOI: 10.5639/gabij.2015.0402.021

Author byline as per print journal: Omotayo Fatokun, PhD; Professor Mohamed Izham Mohamed Ibrahim, PhD; Professor Mohamed Azmi Hassali, PhD Abstract: There are major barriers to generic medicine development and market entry in Malaysia. This mixed method study recommends strategies to increase uptake. Submitted: 25 October 2016; Revised: 15 November 2016; Accepted: 21 November 2016; Published…

Author(s): Omotayo Fatokun, PhD, Professor Mohamed Azmi Hassali, PhD, Professor Mohamed Izham Mohamed Ibrahim, PhD

generic medicines, Malaysia, market entry, patent, pharmaceutical market

DOI: 10.5639/gabij.2016.0504.046

Abstract: Biosimilar products confront novel market authorization and post-marketing use hurdles. Existing evidence is insufficient to fully address physician and payer acceptability thresholds. Submitted: 4 March 2015; Revised: 5 March 2015; Accepted: 9 March 2015; Published online first: 20 March 2015 In this issue of GaBI Journal, Sandorff et al. [1] investigate payer and physician…

Author(s): Professor Alan Lyles, BSPharm, MPH, ScD, PhD (h.c.)

acceptability, biologicals, biosimilars, interchangeability, pricing

DOI: 10.5639/gabij.2015.0401.002

Introduction: Similar Biotherapeutic Products (SBPs or biosimilars) comprise a rapidly expanding area of therapeutics worldwide. However, best practices for their regulation are lacking in many Latin American countries. Methods: The first in a series of educational workshops on SBPs in Latin America was held in Mexico City on 20 January 2015. Didactic presentations covered the…

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

biologicals, biosimilars, follow-on drugs, Latin America, Mexico, regulatory practice

DOI: 10.5639/gabij.2015.0403.031

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 that followed. Despite the backlog, more than enough generics are registered to promote price competition and ensure access to affordable medicines. Submitted: 25 February 2015;…

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

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, MD Introduction: Croatia has introduced a number of reforms to contain pharmaceutical expenditure whilst increasing access to new medicines. These include new regulations and new…

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

Abstract: Over the last few years, there has been a shift in the landscape of blockbuster medicines from small molecule drugs to biologicals. While small molecule drugs still dominate the global pharmaceutical market in terms of numbers, seven of the top 10 best-selling medicines in 2018 were biologicals. The high and rising cost of biologicals…

Author(s): GaBI Journal Editor, GaBI Online Editor

biological, biosimilar, market exclusivity, patent

DOI: 10.5639/gabij.2019.0801.003

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. Submitted: 18 December 2014; Revised: 23 February 2015; Accepted: 9 March 2015; Published online first: 20 March 2015 The legislative basis for the regulation of…

Author(s): Jeewon Joung, PhD

biosimilar, guidelines, regulation, Republic of Korea

DOI: 10.5639/gabij.2015.0402.019

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 impressive number of interesting Symposia, State-of-the-Art Lectures as well as Plenary and Poster Sessions covering all aspects of basic and clinical research and care of…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2014.0304.047