Submitted: 27 January 2020; Revised: 29 January 2020; Accepted: 29 January 2020; Published online first: 25 February 2020 Biological medical products (biologicals) are derived from living cells or organisms. Due to their complex structures and the inherent challenges for manufacturing, a degree of minor variability may exist between different batches of the same product and between…

Author(s): Kevin Klein, PhD

DOI: 10.5639/gabij.2020.0902.012

Contents Editor's Letter Editor’s introduction to the initial issue of the third volume of GaBI Journal Editorial Drug shortages hit US oncologists hard Letters to the Editor Common or distinct INN for biosimilars? Only characteristics of the active substance prior to formulation should be considered Commentary Biosimilar monoclonal antibodies approved for use in the EU…

Contents Editor’s Letter Latest features in GaBI Journal, 2014, Issue 3 Editorial Regional regulatory processes for the approval of biosimilars; differences and similarities Original Research Barriers to market uptake of biosimilars in the US Retrospective chart review: disrupted anaemia control in haemodialysis patients following the switch to an iron sucrose similar (ISS) after long-term treatment…

Editor's Letter

Published on 27 September 2017

Latest features in GaBI Journal, 2017, Issue 3

It is clear that greater use of generics and biosimilars could greatly decrease healthcare costs and thereby increase availability of important medicines. It is equally clear that these potential savings are seldom achieved. The disconnect between what is possible and what is being achieved is related to a lack of trust on behalf of patients,…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2017.0603.020

Contents Editor's Letter Latest features in GaBI Journal, 2012, issue 3-4 Letters to the Editor A bioethicist’s view of the use of biosimilars A clinician’s view of the ethics of the use of biosimilars Editorial Generics policies–a globally-relevant implementation challenge Reference price systems: stakeholder dialogue and involvement Commentary Statin generics: no differences in efficacy after…

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 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…

Original Research

Published on 21 March 2024

Budget impact analysis of a rituximab intravenous biosimilar in patients with follicular lymphoma and large B-cell non-Hodgkin lymphoma in Chile

Author byline as per print journal: Tomás Abbot1, MSc; Nicolás Armijo1, MSc; Robin Piron2, PhD; Manuel Espinoza1,3, PhD Introduction: In Chile, access disparities and budget constraints affect the treatment of non-Hodgkin lymphoma patients, even though therapies like rituximab are covered by the Regime of Explicit Health Guarantees. Biosimilars like Rixathon® off er a compelling alternative…

biosimilars, budget impact analysis, Chile, health system perspective, non-Hodgkin lymphoma, rituximab

DOI: 10.5639/gabij.2024.1301.002

Editor's Letter

Published on 04 May 2016

Editor’s introduction to the initial issue of the fifth volume of GaBI Journal

This issue begins with a Letter to the Editor by Professor Fabio V Teixeira from the Brazilian Inflammatory Bowel Disease (IBD) Society that deals basically with the issue of extrapolation of indications. The letter states that ‘vigilance remains essential’ for the use of this agent in IBD patients. Professor Teixeira’s letter is in response to…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2016.0501.001

Author byline as per print journal: Michael S Reilly, Esq; Ralph D McKibbin, MD, FACP, FACG, AGAF Abstract: The US biosimilar programme has been highly successful with 53 biosimilars approved by the US Food and Drug Administration (FDA) for 17 reference products. As in most advanced nations of Europe, all FDA-approved biosimilars may be substituted…

biosimilarity, interchangeability, misinformation, regulation, uptake

DOI: 10.5639/gabij.2024.1302.009

Editor's Letter

Published on 26 October 2016

Latest features in GaBI Journal, 2016, Issue 3

The informed, appropriate use of follow-on pharmacological agents can provide significant cost savings for patients and payers. These savings can then be used by governments and patients to increase access to health care. However, the actual savings realized depend on a complex series of factors including how ‘similar’ the products actually are to the innovator…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2016.0503.025

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…