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
Interview
Published on 2025-04-15
Turkey’s biotech manufacturing ambitions: Yerlika Biopharma’s strategic role
Abstract:Yerlika Biopharma is a pioneering biotechnology company in Turkey. Company CEO, Hasan Zeytin MD, PhD spoke to GaBI (Generics and Biosimilars Initiative) about the company’s strategic focus, Yerlika is dedicated to reducing the country’s dependency on imported biological products through localizing biopharmaceutical production in Turkey. With state-of-the-art manufacturing facilities the company also aims to expand […]
97 views
Meeting Report
Published on 2025-04-07
Biosimilar Red Tape Elimination Act (S.2305): weakening FDA regulatory standards for biosimilars, undermining physician confidence and jeopardizing patient health
Introduction: In the US, some biosimilars that meet additional requirements may be approved as interchangeable products. This means they can undergo pharmacy-level substitution. An online webinar titled ‘Biosimilar Red Tape Elimination Act (S.2305): Weakening FDA Regulatory Standards for Biosimilars, Undermining Physician Confidence and Jeopardizing Patient Health’, was held to discuss its implications on medicines availability, safety […]
Michael S Reilly, Esq, Ralph D McKibbin, MD, FACP, FACG, AGAF, Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP
160 views
Editor’s Letter
Published on 2025-01-17
Third and final issue of GaBI Journal’s 13th volume
This third issue of GaBI Journal is the last of the volume for this year and marks the end of the first year of me taking up the Editor-in-Chief position for the journal. We have seen a very considerable variety of papers submitted and published during 2024. The first Review Article in this issue by […]
DOI: 10.5639/gabij.2024.1303.032
355 views
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 […]
DOI: 10.5639/gabij.2012.0101.004
232.875 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
198.113 views
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 […]
DOI: 10.5639/gabij.2013.0202.026
189.703 views
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