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: 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: 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

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

Contents Editor’s Letter Fourth and final issue of GaBI Journal’s third volume Editorial Availability and procurement of generics in hospitals among medium-sized European countries Letters to the Editor Access to alternative biopharmaceuticals in low- and middle- income countries Commentary Biosimilars versus ‘biobetters’ — a regulator’s perspective Original Research Availability and procurement conditions of originator and…

Editor's Letter

Published on 17 December 2014

Fourth and final issue of GaBI Journal’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 since 2012) of articles published in the GaBI Journal. I expect that this interest will continue to increase after publication of this fourth and final…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2014.0304.036

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

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

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; Mamdouh Bakhos, MD Introduction: Low molecular weight heparins (LMWHs) are composed of a heterogeneous mixture of oligosaccharides that express a spectrum of biological activities. Studies…

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

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

Abstract: Notwithstanding the scientific and regulatory differences between generic and biosimilar medicines, the European Medicines Agency/Committee for Medicinal Products for Human Use has consistently applied a ‘same active substance’ approach to both. Submitted: 28 November 2014; Revised: 20 January 2015; Accepted: 27 January 2015; Published online first: 30 January 2015 It is often stated that…

Author(s): Barbara J van Zwieten-Boot, Marcel Hoefnagel, Peter MJM Jongen, R Martijn van der Plas

active substance, biosimilar, EMA, Europe, guidelines, regulatory

DOI: 10.5639/gabij.2015.0401.004