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Volume 13

2024

Issue 3

Highlights in this issue:

Aligning environmental, social, and governance to clinical development: moving towards more sustainable clinical trials
US interchangeability designation: are we ready to cut the Gordian knot?
A review of international initiatives on pharmaceutical regulatory reliance and recognition
The challenge for drug shortage: lessons learned from the quality issues of Japanese generic drug companies

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Special Report – Stability Studies

The extended stability studies of anticancer therapies published in 2024 cover 21 small molecules across 10 parenteral drug groups in oncology.

Submit your Research

Practitioners in the scientific research area on the development and use of generics and biosimilar medicines who would like to author papers on related topics, and whose manuscripts comply with the editorial policy of GaBI Journal, are welcome to submit their manuscripts for assessment, peer review and publication in GaBI Journal.

For Authors

All articles are published electronically ahead of print with the definite citation line. Thus, an article will be available online shortly after the author’s approval to print.

Peer Review

All manuscripts submitted to GaBI Journal are subject to a rigorous peer review process.

We welcome suggestions for referees from the author though these recommendations may or may not be used. Names, postal and email addresses of three to four experts in the appropriate area of research should accompany each manuscript submission.

Article Processing Charges

The article will be published online after receipt of the corrected proofs. This is the official first publication citable with the DOI. After release of the printed version, the article can also be cited by issue and page numbers.

About GaBI

Sustainability and equal access to health care for all is at risk due to rapidly increasing costs. The reasons for this are diverse: increased standard of living and life expectancy, but also the high cost of new drug innovations. Today’s society is looking for inexpensive solutions to its ever-increasing demands. Healthcare systems endeavour on the one hand to provide groundbreaking, novel solutions to a greater than ever demand for therapeutic assistance, and on the other hand to achieve this in the most cost-efficient way.

Articles

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Biosimilar trial failed? Investors get their money back: a new insurance model redefines clinical trial financing

Abstract:A new insurance-backed financing model for biosimilars uses AI-powered underwriting to cover clinical trial costs if they fail. This reduces risk, improves capital access, and minimizes equity dilution for developers. Introduction Developing biosimilars has always involved a complex calculus of risk, capital, and time. Now, a newly launched insurance-backed financing model could dramatically change the […]

DOI: 10.5639/gabij.2025.1402.

39 views

Original Research

Published on 2025-04-15

An analysis of policy impacts on the price developments of biological medicines after patent expiration

Introduction/Study objectives: A biosimilar is a biological medicine that is developed to be similar to an existing biological medicine (the ‘reference medicine’) for which marketing exclusivity rights have expired. The prices of such medicines are shaped by regulations onpharmaceutical pricing, or the policy of setting the price of a medicine at certain points in the […]

An analysis of policy impacts on the price developments of biological medicines after patent expiration, Peter Schneider, MA, Alexander Guggenberger, BSc, MSc, Siegfried Eisenberg, BSc, MSc, PhD, Lukas Rainer, BSc, MSc

DOI: 10.5639/gabij.2025.1401.004

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Meeting Report

Published on 2025-04-14

Current trends in biosimilar uptake and special focus on automatic substitution – a symposium report

Abstract:In December 2023, the University of Helsinki, Helsinki University Hospital (HUS), and University Pharmacy (Yliopiston Apteekki) Helsinki collaborated to present the online symposium titled ‘Current Trends in Biosimilar Uptake and Research with Special Focus on Automatic Substitution’. This provided an overview of global trends in biosimilar use and a systematic examination of the implications of automatic substitution […]

Professor Alan Lyles, BSPharm, MPH, ScD, PhD (h.c.), Heinonen E, MD, PhD, Tolonen HM, MSc (Pharm), PhD, Linden K, MSc (Pharm), MSc (Econ), PhD, Sihvo S, PhD, Sarnola K, MSc (Pharm), MSc (Econ), PhD, Airaksinen M, MSc (Pharm), PhD

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Review Article

Published on 2012-02-21

A review of generic medicine pricing in Europe

Introduction: Switching from originator products to generic equivalents is a key method used by governments to reduce costs and keep their healthcare systems sustainable. The aim of this article is to review generic medicine pricing in Europe by analysing the factors that influence them. Methods: The literature review focused on selected studies that highlighted generic […]

Steven Simoens, MSc, PhD

DOI: 10.5639/gabij.2012.0101.004

233.095 views

Original Research

Published on 2013-01-11

The generic pharmaceutical industry: moving beyond incremental innovation towards re-innovation

Background: Due to the declining innovativeness of the classic R & D model in the original pharmaceutical industry, the generic pharmaceutical industry is aiming to become an innovation generator itself. Objective: The objective of this article is to gain insight into the re-innovation model in some of the innovative generic pharmaceutical firms. To this effect, […]

Fereshteh Barei, PhD, Professor Claude Le Pen, PhD, Steven Simoens, MSc, PhD

DOI: 10.5639/gabij.2013.0201.011

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Editorial

Published on 2013-06-12

National and regional activities by sickness funds in Austria to encourage the rational use of medicines

Abstract: Dr Brian Godman reviews the paper by Vogler and Zimmermann on sickness fund activity in Austria to preferentially encourage the prescribing of generics. This is particularly important given the resources that can be released through increased prescribing of generics. Submitted: 10 June 2013; Revised: 11 June 2013; Accepted: 12 June 2013; Published online first: 20 June 2013 Vogler and Zimmermann have […]

Brian Godman, BSc, PhD

DOI: 10.5639/gabij.2013.0202.026

189.759 views