Articles

Abstracted Scientific Content

Published on 12 December 2016

Strategies used to delay or prevent access to affordable generic drugs in the US

Submitted: 28 November 2016; Revised: 29 November 2016; Accepted: 30 November 2016; Published online first: 5 December 2016 In the journal Blood, Jones et al. [1] discuss strategies used by...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0504.051

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Abstracted Scientific Content

Published on 18 April 2016

The case for reforming drug naming

Submitted: 29 February 2016; Revised: 15 March 2016; Accepted: 16 March 2016; Published online first: 29 March 2016 Use of brand name drugs over generic equivalents after expiration of exclusivity...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0501.012

4.974 views

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Original Research

Published on 08 September 2022

Social trust and regional variation in the adoption of biosimilars in Italy and Germany

Introduction/Study Objectives: Adoption of biosimilars has fallen below projections, despite the vigorous implementation of economic incentives, thereby highlighting the importance of behavioural factors such as social trust. This paper analyses...

Author(s): Professor James C Robinson, PhD, MPH

biosimilars, Germany, healthcare costs, Italy, medicine prices, social trust

DOI: 10.5639/gabij.2022.1103.015

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Review Article

Published on 04 May 2023

Statistical tests for detecting reference product change in biosimilar studies

Author byline as per print journal: Jiayin Zheng1, PhD; Peijin Wang`2, MS; Yixin Wang3, PhD; Shein-Chung Chow2, PhD Abstract: For the biosimilarity assessment between a test product and a reference...

DOI: 10.5639/gabij.2023.1202.009

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Abstracted Scientific Content

Published on 02 February 2018

Barriers to generics policy reform: a US case study

Submitted: 29 December 2017; Revised: 5 January 2018; Accepted: 12 January 2018; Published online first: 19 January 2018 A recent comparison of generic drug markets [1] explores the history of...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2018.0701.009

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Commentary

Published on 07 April 2016

Low-cost generic drug programs in the US: implications for payers and researchers

Abstract: Low-cost generic drug programs (LCGPs) provide affordable generics in the US. However, LCGPs have implications for managed care organizations and researchers relying on claims data. Submitted: 7 March 2016;...

Author(s): Joshua D Brown, PharmD, MS

generic medicines, low-cost generic drug programs, quality assessment, United States healthcare system

DOI: 10.5639/gabij.2016.0501.003

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Editor's Letter

Published on 05 September 2014

Latest features in GaBI Journal, 2014, Issue 3

This issue of the GaBI Journal begins with editorial comments from our Deputy Editor-in-Chief Dr Robin Thorpe concerning the Review Article by Azevedo et al. covering biosimilar regulations and their...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2014.0303.026

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Review Article

Published on 26 September 2022

Development of Ph. Eur. standards for therapeutic monoclonal antibodies: infliximab case study

Abstract: This article describes the European Pharmacopoeia (Ph. Eur.) exploratory study on infliximab as a test case for developing public standards for monoclonal antibodies. The design and outcome of the...

Author(s): Mihaela Buda, PhD

flexibility, infliximab, monographs, pharmacopoeia, public standards, reference preparations

DOI: 10.5639/gabij.2022.1103.017

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Opinion

Published on 17 December 2021

Biosimilarity is not a transitive property: implication for interchangeability, naming and pharmacovigilance

Abstract: Current regulations do not require a given biosimilar to remain similar to its reference biological over time. However, two products that were initially deemed biosimilar or interchangeable could each...

Author(s): Pablo Matar, PhD

divergence, drift, evolution, interchangeability, pharmacovigilance, variability

DOI: 10.5639/gabij.2022.1101.006

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Abstracted Scientific Content

Published on 23 September 2015

Escalating prices of generic drugs targeted by US anti-gouging legislation

Submitted: 29 January 2019; Revised: 4 February 2019; Accepted: 5 February 2019; Published online first: 14 February 2019 Generic prescription drug prices have been escalating rapidly in the US. In...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2019.0802.010

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Meeting Report

Published on 03 October 2016

Demonstrating interchangeability and biosimilarity for US biosimilars

Abstract: The US Food and Drug Administration (FDA) outlines its approach to biosimilarity and interchangeability at the 2016 Generic Pharmaceutical Association Biosimilars Council Conference. Topics covered include the FDA definition...

Author(s): GaBI Journal Editor

biologicals, biosimilar, biosimilarity, interchangeability, regulation

DOI: 10.5639/gabij.2016.0503.035

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Special Report

Published on 11 July 2024

Extended stability data on small molecule anticancer medicinal products – anything new? any additional information necessary?

Abstract: Monoclonal antibodies and cell therapies play an increasingly significant role in anticancer therapy, but small molecules remain an essential part of combination chemotherapy. Despite the publication of many studies...

Author(s): Irene Krämer, PhD, Judith Thiesen, PhD

anticancer drugs, cytotoxic, in-use stability, parenteral administration

DOI: 10.5639/gabij.2024.1302.010

4.407 views

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