Articles

Perspective

Published on 08 August 2023

Ethnic sensitivity assessments in biosimilar monoclonal antibodies clinical development programmes: necessary or not?

Author byline as per print journal: Sandeep N Athalye1, MBBS, MD; Dev B Baruah1, MPharm; Shivani Mittra1, MPharm, PhD; Ankit Ranpura1, MD; Kuldeep Kumar1, PhD; Elena Wolff-Holz2, MD Abstract: Ethnic...

biosimilar development, ethnic sensitivity assessments, global access, monoclonal antibodies, multi-regional clinical trials, regulatory reforms

DOI: 10.5639/gabij.2023.1202.010

10.991 views

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Original Research

Published on 02 September 2014

Availability and procurement conditions of originator and generic medicines in hospitals – an exploratory study in five medium-sized European countries

Aim: To explore whether medicines used in hospitals in European countries are supplied as originators or generic medicines, and to investigate the procurement conditions, including the extent of discounts at...

Author(s): Sabine Vogler, PhD, Nina Zimmermann, MA, Jan Mazag, PharmaDr

cardiovascular medicines, discounts, generics, procurement, rebates, tender

DOI: 10.5639/gabij.2014.0304.040

10.988 views

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Pharma News

Published on 18 March 2020

Top developments in biosimilars during 2019

Submitted: 3 February 2020; Revised: 12 February 2020; Accepted: 18 February 2020; Published online first: 25 February 2020 2019 has been a busy year for biosimilars; there have been a record...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2020.0901.007

10.867 views

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Original Research

Published on 03 August 2020

Local policies on biosimilars: are they designed to optimize use of liberated resources?

Author byline as per print journal: Arianna Bertolani, PhD; Claudio Jommi, MS Study Objectives: Different policies have been implemented to enhance uptake of biosimilars. Regarding policies focussing on the demand-side,...

Author(s): Arianna Bertolani, PhD, Claudio Jommi, MS

biosimilars, Italian national health service, local policies

DOI: 10.5639/gabij.2020.0904.027

10.849 views

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Review Article

Published on 29 September 2021

The European framework for intellectual property rights for biological medicines

Author byline as per print journal: Josette Sciberras, MBA, MA Bioethics, BPharm (Hons); Raymond Zammit, SThD; Patricia Vella Bonanno, PhD Introduction: The Pharmaceutical Strategy for Europe (2020) proposes actions related to...

biological medicines, European intellectual property rights, market access, pricing, R & D

DOI: 10.5639/gabij.2021.1004.022

10.759 views

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Original Research

Published on 23 February 2021

Reasons for patients’ generic drug switching at the pharmacy counter: a pilot study

Author byline as per print journal: Pieter J Glerum1,2, MSc; Mert Hayta1,3, PharmD, MSc; David M Burger4, PharmD, PhD; Cees Neef5, PharmD, PhD; Marcel L Bouvy3, PharmD, PhD; Marc Maliepaard1,6,...

Brand-name drugs, drug switching, generic drugs, generics substitution, interchangeability, pharmacy practice

DOI: 10.5639/gabij.2021.1003.014

10.758 views

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Perspective

Published on 06 July 2016

Pharmacovigilance on biologicals and biosimilars: a Danish perspective

Abstract: The development of biological medicinal products is in rapid growth and as patents for reference products expire, new biosimilar products become available. This has a marked impact on several...

Author(s): Benedicte Lunddahl, DVM

biological medicinal products, biosimilars, national competent authority, pharmacovigilance

DOI: 10.5639/gabij.2016.0503.030

10.732 views

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Editor's Letter

Published on 14 November 2012

Latest features in GaBI Journal, 2012, issue 3-4

This issue of the GaBI Journal uses a number of article formats to cover a range of issues related to generics and biosimilars. In Letters to the Editor, Dr Carlo...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2012.0103-4.037

10.613 views

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Editorial

Published on 12 June 2017

Trends and challenges in biosimilars pricing and reimbursement policies in Europe and beyond

Abstract: Biosimilars policies are more controversial than those for generics. However, it is only a question of time before progress in biosimilars matches that of generics worldwide. Submitted: 21 April...

Author(s): Alessandro Curto, MSSc

biosimilars, Europe, pricing, reimbursement

DOI: 10.5639/gabij.2017.0602.012

10.547 views

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Original Research

Published on 03 August 2020

Systematic analysis of injection-site pain and reactions caused by subcutaneous administration of the adalimumab biosimilar FKB327 versus the adalimumab reference product via different delivery methods

Author byline as per print journal: Rieke Alten1, MD, PhD; Herbert Kellner2, MD; Malcolm Boyce3, MD; Takuma Yonemura4, MD; Takahiro Ito5, MSc; Mark C Genovese6, MD Introduction/Study objectives: FKB327 is...

adalimumab, anti-TNF therapy, biosimilars, clinical trials, injection-site pain, rheumatoid arthritis

DOI: 10.5639/gabij.2020.0903.019

10.539 views

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Original Research

Published on 14 December 2016

Naming and labelling of biologicals – a survey of US physicians’ perspectives

Introduction: The US Food and Drug Association (FDA) released its requirements for the non-proprietary naming of biological products in January 2017. Before the FDA’s release, the Alliance for Safe Biologic...

Author(s): Harry L Gewanter, MD, FAAP, FACR, Michael S Reilly, Esq

ASBM, biosimilar, interchangeability, labelling, legislation, naming

DOI: 10.5639/gabij.2017.0601.003

10.416 views

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