Contents Editor’s Letter Editor’s introduction to the initial issue of the fourth volume of GaBI Journal Editorial Biosimilars: patient and physician acceptability is the fifth hurdle to market competition Letters to the Editor Generic medicines policy in Qatar Commentary The EU regulatory approach to generics and biosimilars is essentially similar Original Research Payer and physician…

Contents Editor’s Letter Latest features in GaBI Journal, 2017, Issue 3 Commentary Patent expiry and costs for anti­cancer medicines for clinical use Original Research A survey of Australian prescribers’ views on the naming and substitution of biologicals Review Article Biosimilars in Italy: what do real-world data reveal? Special Report Physician associations comment on FDA’s interchangeability…

The editors and publisher wish to express their gratitude to the colleagues listed below for their valuable contribution to the peer review process for the Generics and Biosimilars Initiative Journal (GaBI Journal) in 2019. Dr Chiann Chang, Brazil Professor Moses SS Chow, USA Dr Brian Godman, UK Professor Alan Lyles, USA Dr Robin Thorpe, UK Dr Marco…

Contents Editor’s Letter Latest features in GaBI Journal, 2018, Issue 3 Commentary Medicines regulation in the MENA region and the importance of the World Health Organization’s INN proposal of Biological Qualifier Original Research Extended stability of a biosimilar of trastuzumab (CT-P6) after reconstitution in vials, dilution in polyolefin bags and storage at various temperatures Implementing…

The editors and publisher wish to express their gratitude to the colleagues listed below for their valuable contribution to the peer review process for the Generics and Biosimilars Initiative Journal (GaBI Journal) in 2021. Dr Chiann Chang, Brazil Associate Professor Dr Devrim Demir Dora, Turkey Dr Thijs J Giezen, The Netherlands Dr Weng Fai Lai, Singapore Dr…

Contents Editor’s Letter Editor’s introduction to the initial issue of the fifth volume of GaBI Journal Letters to the Editor First biosimilar of infliximab approved in Brazil: response from the Brazilian IBD society Commentary Low-cost generic drug programs in the US: implications for payers and researchers Waiver of consent for retrospective chart review studies Original…

Contents Editor's Letter What to look forward to in GaBI Journal, 2014, Issue 2 Editorial Complex molecules – current developments Commentary Defining and characterizing nonbiological complex drugs (NBCDs) – Is size enough? The case for liposomal doxorubicin generics (‘liposomal nanosimilars’) for injection Original Research Biosimilars naming, label transparency and authority of choice – survey findings…

Contents Editor’s Letter Latest features in GaBI Journal, 2015, Issue 3 Editorial Advances in analytical characterization of biosimilars Letters to the Editor Access to safe and effective biopharmaceuticals Commentary The challenges of nomenclature – INN, biosimilars and biological qualifiers Review Article Biosimilars patent litigation in the EU and the US: a comparative strategic overview Biosimilars:…

Contents Editor’s Letter What to look forward to in GaBI Journal, 2016, Issue 2 Editorial Adjusted indirect comparisons between generics – bioequivalence and interchangeability Review Article Assessment of the interchangeability between generics  Legal Biosimilars patent litigation in Canada and Japan: a comparative strategic overview and EU and US update Perspective New monoclonal antibody biosimilars approved…

Contents Editor’s Letter Fourth and final issue of GaBI Journal’s fifth volume Editorial Physicians, Hippocrates and biosimilars: applying ancient principles in a modern society Original Research Naming and labelling of biologicals – the perspective of hospital and retail pharmacists Assessment of active pharmaceutical ingredients in drug registration procedures in Pakistan: implications for the future Review…

Contents Editor’s Letter Editor’s introduction to the initial issue of the ninth volume of GaBI Journal Original Research Stability of the trastuzumab biosimilar ABP 980 compared to reference product after intravenous bag preparation, transport and storage at various temperatures, concentrations and stress conditions Pharmaceutical pricing policy in Saudi Arabia: findings and implications Perspective An evolving…

Introduction: The European Union (EU) and the European Medicines Agency (EMA) have led the development of a regulatory framework for biosimilars since 2004. By end of December 2019, 64 biosimilars of 15 originator biological medicines have a marketing authorization in Europe. Now, for the second time, the Alliance for Safe Biologic Medicines (ASBM) asked European…

Author(s): Madelaine A Feldman, MD, FACR, Michael S Reilly, Esq

biological medicines, biosimilar, EU, prescribers, substitution, survey

DOI: 10.5639/gabij.2020.0903.020