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

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

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 events in South Africa that led to claims of delay in marketing approval of generic drug products. The authors discuss the relationship between regulatory policies…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2015.0402.013

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 world. Population growth and ageing will increase the number of new cancer cases in the coming years [1]. Furthermore, cancer is becoming a more widely…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2015.0401.012

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 of ‘copy’ versions of the off-patent biologicals, generally known as biosimilars (subsequent entry biologics in Canada). The reduced clinical package and the potential for extrapolation…

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

Abstract: Biosimilars are copies of original biological medicines. Biosimilarity is a new concept in drug development. Physicians prescribing biologicals need more neutral information on the quality, safety and efficacy of biosimilars. Submitted: 27 November 2014; Revised: 15 December 2014; Accepted: 18 December 2014; Published online first: 19 December 2014 Introduction The European Union (EU) was…

Author(s): Adjunct Professor Pekka Kurki, MD, PhD

biosimilars, comparability, interchangeability, prescribers, regulators

DOI: 10.5639/gabij.2015.0401.008

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

Study objectives: In Latin America, many governments have attempted to address biosimilar safety and efficacy concerns by developing abbreviated regulatory pathways to increase access while controlling quality. This study explores discount and evidence requirements for payers and physicians to provide access to and prescribe biosimilars in Argentina, Brazil and Mexico. Methods: We conducted targeted literature…

Author(s): André Vidal Pinheiro, PhD, Associate Professor Valderilio Feijó Azevedo, MD, PhD, MSc, Daniele Severi Bruni, MPhil, Ronald Halbert, MD, MPH, Erik Sandorff, MA, MBA

biosimilar pharmaceuticals, discounts, drug industry, Latin America, prescribing

DOI: 10.5639/gabij.2015.0401.005

Objective: One of the questions that the advent of biosimilars raises is whether the different nature of biological medicines would also imply the need for a different policy approach by Member States in the European Union (EU). To assess the policy environment the European Biopharmaceutical Enterprises (EBE) conducted a brief descriptive policy survey of pricing…

Author(s): European Biopharmaceutical Enterprises

biological medicines, biosimilars, off-patent market, pricing and reimbursement policy

DOI: 10.5639/gabij.2015.0401.006

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 biosimilars industry. One of the most important milestones during 2014 was the news that the US Food and Drug Administration (FDA) had accepted several biosimilars…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2015.0401.010

Submitted: 24 January 2015; Revised: not applicable; Accepted: 27 January 2015; Published online first: 30 January 2015 The ‘International Generic Drug Regulators Pilot’ (IGDRP) seems to be a true model for the future of authorization processes. It was first founded back in April 2012 with the aim to promote the international collaboration within authorization processes…

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

DOI: 10.5639/gabij.2015.0401.011

Abstract: Qatar’s pharmaceutical market is likely to remain highly dependent on imports. The use of generic medicines remains a great challenge to the country. Submitted: 18 December 2014; Revised: 28 January 2015; Accepted: 1 February 2015; Published online first: 13 February 2015 Qatar is the world’s richest country per capita. The country established its National…

Author(s): Professor Mohamed Izham Mohamed Ibrahim, PhD

generic medicines, pharmaceutical policy, Qatar

DOI: 10.5639/gabij.2015.0401.003