Articles


Published on 21 June 2017

2017/2 GaBI Journal Table of Contents

Contents Editor’s Letter What to look forward to in GaBI Journal, 2017, Issue 2 Editorial Trends and challenges in biosimilars pricing and reimbursement policies in Europe and beyond Commentary Strategies for pricing of pharmaceuticals and generics in developing countries Original Research What pricing and reimbursement policies to use for off-patent biologicals in Europe? – results…


2.528 views

Regulatory

Published on 25 March 2020

Regulatory pathway for approval of ‘biosimilars’ in Iran

Abstract: Iran was the first country in the MENA (Middle East and North Africa) region to publish a legal framework for the registration of biosimilars. This framework is defined by the Iranian Food and Drug Administration (IFDA). It defines biosimilars as biological products that have the same Active Pharmaceutical Ingredient (API) as the Reference Medicinal…

Author(s): Jalal Naeli, MD

biopharmaceuticals, Iran, reference medicinal product


2.749 views

Published on 09 March 2021

2021/1 GaBI Journal Table of Contents

Contents Editor’s Letter First 2021 GaBI Journal issue highlights Original Research Biosimilars – status in July 2020 in 16 countries An assessment of trends in the Iranian pharmaceutical market following domestic production of selected medications (2007‒2017) and new considerations for health policymakers Review Article Continuous manufacturing versus batch manufacturing: benefits, opportunities and challenges for manufacturers…


1.771 views

GJ 2024-1 Cover Web V24H08 Table Contents

Published on 15 April 2024

2024/1 GaBI Journal Table of Contents

Editor’s Letter First 2024 GaBI Journal issue highlights Original Research Budget impact analysis of a rituximab intravenous biosimilar in patients with follicular lymphoma and large B-cell non-Hodgkin lymphoma in Chile Pharmacokinetic bioequivalence studies of a new Etoricoxib tablet formulation developed using proprietary MiST technology — risk assessment and mitigation using GastroPlus software Perspective Comparative efficacy…


54 views

Published on 29 January 2015

2014/4 GaBI Journal Table of Contents

Contents Editor’s Letter Fourth and final issue of GaBI Journal’s third volume Editorial Availability and procurement of generics in hospitals among medium-sized European countries Letters to the Editor Access to alternative biopharmaceuticals in low- and middle- income countries Commentary Biosimilars versus ‘biobetters’ — a regulator’s perspective Original Research Availability and procurement conditions of originator and…


3.493 views

Published on 01 January 2018

2017/4 GaBI Journal Table of Contents

Contents Editor’s Letter Fourth and final issue of GaBI Journal’s sixth volume Letters to the Editor Clear naming, traceability of biological medicines will protect patients Comment on the non-biological complex drugs paper Commentary Global policies on pharmacy-mediated substitution of biosimilars: a summary Original Research Pharmacy-mediated substitution of biosimilars – a global survey benchmarking country substitution…


3.018 views

Published on 29 September 2021

2021/3 GaBI Journal Table of Contents

Contents Editor’s Letter Latest features in GaBI Journal, 2021, Issue 3 Original Research Pharmacokinetics and bioequivalence of generic etoricoxib in healthy volunteers Reasons for patients’ generic drug switching at the pharmacy counter: a pilot study Review Article A critical review of substitution policy for biosimilars in Canada Microbiological, scientific and regulatory perspectives of hand sanitizers…


1.631 views

Table Contents

Published on 03 January 2023

2022/3 GaBI Journal Table of Contents

Contents Editor’s Letter The importance of trust Original Research Social trust and regional variation in the adoption of biosimilars in Italy and Germany US prescribers’ attitudes and perceptions about biosimilars Review Article Development of Ph. Eur. standards for therapeutic monoclonal antibodies: infliximab case study Meeting Report Key factors for successful uptake of biosimilars: Europe and the US


1.143 views

Published on 16 October 2014

2012/1 GaBI Journal Table of Contents

Contents Editor's Letter Introduction to the GaBI Journal Editorial Generic medicine pricing: on track in Europe? Commentary Innovator companies should focus on innovations Review Article A review of generic medicine pricing in Europe Biologicals and biosimilars: a review of the science and its implications A patient-centred paradigm for the biosimilars market European payer initiatives to…


3.603 views

Thank you to reviewers

Published on 09 March 2021

Thank you to reviewers 2020

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 2020. Dr Adel AL Harf, Saudi Arabia Professor Alain Astier, France Professor Moses SS Chow, USA Dr Alessandro Curto, Italy Professor Theodor…


2.617 views

Published on 24 April 2017

2017/1 GaBI Journal Table of Contents

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…


2.695 views

Published on 05 January 2018

2018/1 GaBI Journal Table of Contents

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…


2.679 views