Author byline as per print journal:  Brian Godman1,2,3, BSc, PhD; Bjorn Wettermark1,4, MSc, PhD; Iain Bishop5, BSc; Thomas Burkhardt6, MSc; Jurij Fürst7, PhD; Kristina Garuoliene8, MD; Ott Laius9, MScPharm; Jaana E Martikainen10, Lic Sc(Pharm); Catherine Sermet11, MD; Inês Teixeira12, BA, MSc; Corrine Zara13, PharmD; Lars L Gustafsson1, MD, PhD Introduction: Pharmaceutical expenditure is increasingly scrutinised by payers of health…

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

demand measures, generics, pharmaceuticals, pricing

DOI: 10.5639/gabij.2012.0101.007

Abstract: The advent of similar biological medicinal products or ‘biosimilars’ in Europe in the 2000s has led to development of a global biosimilars market and regulatory frameworks designed specifically for approval of biosimilars. Like originator biologicals, biosimilars exhibit greater molecular complexity than small-molecule drugs, including generics. Current estimates suggest that biosimilars are more expensive and…

Author(s): James N Class, PhD, Lauren Langis, JD

biosimilars, medical devices, outcomes, patients, prescribers, public policy

DOI: 10.5639/gabij.2012.0101.006

Abstract: Biopharmaceuticals are medicines whose active drug substance is made by living cells. Copies of these drugs, called biosimilars, are not identical to their reference drug and therefore specific regulatory requirements for registration apply. Whereas pharmaceutical quality evaluation requires a full dossier and a detailed comparative analysis to the reference drug, non-clinical and clinical requirements…

Author(s): Professor Paul J Declerck, PhD

biological, biopharmaceutical, biosimilar, interchangeability

DOI: 10.5639/gabij.2012.0101.005

Introduction: Switching from originator products to generic equivalents is a key method used by governments to reduce costs and keep their healthcare systems sustainable. The aim of this article is to review generic medicine pricing in Europe by analysing the factors that influence them. Methods: The literature review focused on selected studies that highlighted generic…

Author(s): Steven Simoens, MSc, PhD

Europe, generic medicines, pharmaceutical policy, pricing

DOI: 10.5639/gabij.2012.0101.004

Abstract: Despite biopharmaceuticals having an enormous potential value for our health, they have also become a serious threat to our healthcare systems. Submitted: 22 June 2011; Revised manuscript received: 6 October 2011; Accepted: 11 October 2011 Recombinant drugs, or biologicals as they are widely termed, are highly complex drug substances that have added tremendous treatment…

Author(s): Professor Theodor Dingermann, PhD

DOI: 10.5639/gabij.2012.0101.003

Abstract: There are many variables responsible for the pricing of generic medicines in Europe. This editorial looks at the many policy initiatives currently being undertaken. Submitted: 3 November 2011; Revised manuscript received: 23 November 2011; Accepted: 14 December 2011 In this first issue of the Generics and Biosimilars Initiative Journal, Professor Steven Simoens describes the…

Author(s): Associate Professor Marc A Koopmanschap, PhD

DOI: 10.5639/gabij.2012.0101.002

Editor's Letter

Published on 14 February 2012

Introduction to the GaBI Journal

I am proud and pleased to be able to write the introduction to this first issue of the Generics and Biosimilars Initiative Journal (GaBI Journal). This journal is designed to complement GaBI Online which has successfully covered generic and biosimilar issues since 2009. The Publisher, the members of our Editorial Boards, and I, that is, ‘we’;…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2012.0101.001

Contents Editor’s Letter Editor’s introduction to the initial issue of the sixth volume of GaBI Journal Letters to the Editor Pricing strategies for pharmaceuticals in developing countries: what options do we have? Original Research Naming and labelling of biologicals – a survey of US physicians’ perspectives Review Article Ocular emulsions and dry eye: a case…

Contents Editor’s Letter Editor’s introduction to the initial issue of the seventh volume of GaBI Journal Commentary EU Member States have tools to reduce costs of bestseller biologicals but can they use them? Original Research Analysis of Drug Master Files registered in Japan: aiming for a stable supply of active pharmaceutical ingredients Review Article Biosimilar…

Contents Editor's Letter What to look forward to in GaBI Journal, 2012, issue 2 Editorial Equal protection under the law: Children and the Best Pharmaceuticals for Children Act Regulatory Tighter EU rules on pharmacovigilance for biologicals Review Article What lessons can be learned from the launch of generic clopidogrel? Payers endorse generics to enhance prescribing…

Contents Editor’s Letter Latest features in GaBI Journal, 2019, Issue 3 Commentary Ever-changing landscape of biosimilars in Canada; findings and implications from a global perspective Original Research Pharmacy chain drives choice among manufacturers of generic drugs in the US Medicare population Review Article An ever-evolving landscape: an update on the rapidly changing regulation and reimbursement…

Author(s): Christopher Gillespie, Jennifer Campbell, Michael Phillips