Abstract: Nomenclature for biosimilars is a controversial issue. In this issue of GaBI Journal, a paper by Sarshad et al. considers the US FDA’s published system for this and concludes that it will be a positive solution to a global issue. But this may be a premature judgement. Submitted: 1 January 2019; Revised: 3 January…

Author(s): Robin Thorpe, PhD, FRCPath

biosimilars, INN, nomenclature, US Food and Drug Administration (FDA)

DOI: 10.5639/gabij.2018.0704.029

Abstract:  Four changes to the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act will markedly improve these programmes: expanded attention paid to neonatal studies, support for the off -patent programme, timing and submission of paediatric plans, and the per­manence of the legislation. Submitted: 30 November 2011; Revised manuscript received: 2 March 2012;…

Author(s): Professor Daniel Kelly Benjamin Jr, MD, MPH, PhD, Professor Gregory L Kearns, PharmD, PhD

Best Pharmaceuticals for Children Act, clinical studies, legislation, neonates, off-patent drugs

DOI: 10.5639/gabij.2012.0102.014

Introduction: To describe pharmaceutical pricing and reimbursement systems in 29 European countries with regard to medicines, particularly generics, and their possible impact on generics uptake. Method: Data collection on pharmaceutical pricing and reimbursement policies with the staff of competent authorities. Results: In most European countries the prices of medicines are controlled at the stage of manufacture (ex-factory price)…

Author(s): Sabine Vogler, PhD

generics policies, generics substitution, INN prescribing, pricing, reference pricing system, reimbursement

DOI: 10.5639/gabij.2012.0102.020

Author byline as per print journal: Professor Brian Godman1,2,3, BSc, PhD; Amanj Kurdi1,4, PhD; Holly McCabe5, MSc; Sean MacBride-Stewart6, MSc; Axel Leporowski5, MD; Simon Hurding7, MD; Professor Marion Bennie1, MSc; Professor Alec Morton5, PhD Introduction: There has been a considerable increase in the use of proton pump inhibitors (PPIs) in recent years due to their effectiveness…

Author(s): Amanj Kurdi, BSc, PhD, Axel Leporowski, MD, Brian Godman, BSc, PhD, Holly McCabe, MSc, Marion Bennie, MSc, Professor Alec Morton, PhD, Sean MacBride-Stewart, MSc, Simon Hurding, MD

drug utilization, expenditure, generics, PPIs, reforms, Scottish NHS

DOI: 10.5639/gabij.2018.0704.030

Author byline as per print journal: Christoph Baumgärtel1, MD; Brian Godman2,3,4, BSc, PhD; Rickard E Malmstrom5, MD, PhD; Morten Andersen6, MD, PhD; Mohammed Abuelkhair7, PharmD; Shajahan Abdu7, MD; Marion Bennie8,9, MSc; Iain Bishop9, BSc; Thomas Burkhardt10, MSc; Sahar Fahmy7, PhD; Jurij Furst11; Kristina Garuoliene12, MD, PhD; Harald Herholz13, MPH; Marija Kalaba14, MD, MHM; Hanna Koskinen15, PhD;…

Author(s): Christoph Baumgärtel, MD, MSc, et al.

clopidogrel, demand measures, generics, pricing

DOI: 10.5639/gabij.2012.0102.016

Abstract:  Marketed medicines that have passed bioequivalence testing should in general be substitutable. However, for a variety of reasons, caution may be warranted, particularly with regard to narrow therapeutic index drugs and the indiscriminate use of biosimilars. The Royal Dutch Pharmacists Association (KNMP) has published professional guidelines for community pharmacies concerning generic substitution. The guidelines…

Author(s): Leonora Grandia, PharmD, Professor Arnold G Vulto, PharmD, PhD, FCP

biologicals, biosimilars, Dutch guidelines, generics substitution, interchangeability, narrow therapeutic index drugs

DOI: 10.5639/gabij.2012.0102.021

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: 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

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

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

Author byline as per print journal: Helle Håkonsen, MScPharm, PhD; Else-Lydia Toverud, MScPharm, PhD Introduction: With a few exceptions, generic drug use has been promoted in western countries by allowing pharmacists to substitute drugs defined as therapeutically equivalent generics. The aim of this literature review is to summarise the research on the patients’ perspectives of generics substitution…

Author(s): Else-Lydia Toverud, MScPharm, PhD, Helle Håkonsen, MScPharm, PhD

cost containment, generic drugs, generics prescribing, generics substitution, patient perspectives

DOI: 10.5639/gabij.2012.0101.008

Author byline as per print journal: Brian Godman1,2,3, BSc, PhD; Mohammed Abuelkhair4, PharmD; Agnes Vitry5, PharmD, PhD; Shajahan Abdu4, MD; Marion Bennie6,7, MSc; Iain Bishop7, BSc; Sahar Fahmy4, PhD; Kristina Garuoliene8, MD, PhD; Harald Herholz9, MPH; Andrew Martin10, BSc, MPharmS; Rickard E Malmstrom11, MD, PhD; Professor Saira Jan12,13, PharmD, PhD; Ulrich Schwabe14, MD, PhD; Catherine Sermet15,…

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

demand-side measures, generics, pharmaceuticals, pricing

DOI: 10.5639/gabij.2012.0102.017