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

Abstract: Major cost savings are achievable in pharmacotherapy in the European Union since biosimilars to most best-selling biological medicinal products have been licensed. Unfortunately, the window of opportunity may be missed since neither national pricing, reimbursement and procurement systems nor prescribers are well prepared for biosimilars’ entry to the market. Submitted: 9 March 2018; Revised:…

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

automatic substitution, biosimilars, cost savings, interchangeability, payers, prescribers

DOI: 10.5639/gabij.2018.0701.002

Author byline as per print journal: Valderílio Feijó Azevedo1,2, Alejandra Babini3,4, Fabio Vieira Teixeira5,6, Igor Age Kos1,2, Pablo Matar7 Introduction: The Latin American Forum on Biosimilars (FLAB) is an annual meeting that brings together various stakeholders, including key opinion leaders, the pharmaceutical industry, academics, patients, lawyers and other healthcare professionals, to present and discuss recent…

Author(s): Alejandra Babini, Associate Professor Valderilio Feijó Azevedo, MD, PhD, MSc, Igor Age Kos, Pablo Matar, PhD, Professor Fabio V Teixeira, MSc, MD, PhD

biosimilarity, extrapolation, infliximab, interchangeability, monoclonal antibodies, rituximab

DOI: 10.5639/gabij.2016.0502.017

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

Abstract:  In recognition of the many ethically sensitive issues raised by the production and use of biosimilar medicinal products, the author imagines having to answer the non-multiple choice question ‘From the ethical point of view, what is the most important issue raised by biosimilars?’, and endeavours to explain why the proposed answer is ‘safety’. Submitted:…

Author(s): Carlo Petrini, PhD

bioethics, drugs, ethics committees, legislation, risk, safety

DOI: 10.5639/gabij.2012.0103-4.034

Abstract: Representatives from Amgen and Actavis have spoken to GaBI (Generics and Biosimilars Initiative) about biosimilars. Topics covered included the clinical development of biosimilars, the need for further education, how the partnership model between the companies was working, the commercialization of biosimilars and their views on non-proprietary names for biosimilars Biotech giant Amgen and generics…

Author(s): GaBI Journal Editor

biosimilar, clinical development, commercializaiton, INN

DOI: 10.5639/gabij.2014.0303.035

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: Peter J Pitts, BA; Michael S Reilly, Esq Abstract: The World Health Organization should finalize its Biological Qualifier guidance. Distinguishable naming will allow quick and accurate tracing of the manufacturer, should adverse events occur and improve patient safety by reducing confusion and mishaps. This will ensure that developing nations, including…

Author(s): Michael S Reilly, Esq, Peter J Pitts, BA

Biological Qualifier (BQ), biosimilar, INN, medicines regulation, MENA (Middle East and North Africa)

DOI: 10.5639/gabij.2018.0703.021

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

Author byline as per print journal: Eric CK Siu1,4, MSc, PhD; Anne Tomalin2,4, BA, BSc; Kevin West3,4, BA; Sandra Anderson4, BA, MBA; George Wyatt1,4, BSc, MBA Abstract: Since the introduction of the first infliximab biosimilar, Inflectra®, significant changes have taken place in the Canadian biosimilar landscape, and both the regulatory and the reimbursement processes have…

Author(s): Anne Tomalin, BA, BSc, Eric CK Siu, MSc, PhD, George Wyatt, BSc, MBA, Kevin West, BA, Sandra Anderson, BA, MBA

biosimilars, CADTH CDR, CADTH pCODR, Health Canada, INESSS, pCPA

DOI: 10.5639/gabij.2019.0803.014

Received: 27 March 2012; Accepted: 22 May 2012 The new EU pharmacovigilance legislation which comes into force in July 2012 will include a tightening of requirements relating to product information and identification, as well as the regulations surrounding biosimilars and automatic substitution by pharmacists. The new regulations will provide a legal framework for patients to report adverse events…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2012.0102.015

Abstract: For harmonization of the authorization requirements for specific generic applications within the EU, consistent criteria were drafted for 16 active substances, which are out now for public consultation. Submitted: 2 January 2014; Revised: 6 January 2014; Accepted: 7 January 2014; Published online first: 20 January 2014 Official draft guidance has recently become available for…

Author(s): Christoph Baumgärtel, MD, MSc

authorization, bioequivalence, generics, product-specific bioequivalence guidance

DOI: 10.5639/gabij.2014.0301.009