Articles

Meeting Report

Published on 25 March 2025

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...

Author(s): Michael S Reilly, Esq, Ralph D McKibbin, MD, FACP, FACG, AGAF, Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP, Andrew Spiegel, Esq

interchangeable biosimilar, misinformation, switch studies

DOI: 10.5639/gabij.2025.1401.005

621 views

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Original Research

Published on 08 April 2025

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...

Author(s): Peter Schneider, MA, Alexander Guggenberger, BSc, MSc, Siegfried Eisenberg, BSc, MSc, PhD, Lukas Rainer, BSc, MSc

biosimilars, cost containment, pharmacoeconomics, policy measure savings, pricing

DOI: 10.5639/gabij.2025.1401.004

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Letters to the Editor

Published on 14 January 2025

Comment on the article ‘Misinformation about interchangeable biosimilars’

Abstract:  The critique of Reilly and McKibben of the meta-analysis conducted by Herndon et al. is factually flawed on several important points. As a result, the conclusions of Reilly and...

Author(s): Hillel P Cohen, PhD, Caridad Pontes, MD, PhD, Fernando de Mora, MBA, PhD

biopharmaceutical, critique, interchangeable biosimilar, meta-analysis, misinformation

DOI: 10.5639/gabij.2025.1401.003

606 views

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Editor's Letter

Published on 10 April 2025

Editor’s introduction to the initial issue of the 14th volume of GaBI Journal

In this first issue of 2025, we have some controversial criticism of an article previously published in GaBI Journal [1}, as well as a paper on pricing of biosimilars/biologicals after...

Author(s): Robin Thorpe, PhD, FRCPath

DOI: 10.5639/gabij.2025.1401.001

49 views

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Interview

Published on 07 November 2024

Transforming health care: CinnaGen’s leadership in follow-on biologicals/biosimilars development and market expansion

Abstract: CinnaGen, the largest biopharmaceutical company in the MENA region, is a leader in developing follow-on biologicals/biosimilars. Dr Haleh Hamedifar, Chairperson of CinnaGen, spoke to GaBI (Generics and Biosimilars Initiative)...

Author(s): GaBI Journal Editor

biosimilars, clinical development, commercialization, MENA (Middle East and North Africa)

DOI: 10.5639/gabij.2024.1303.037

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Perspective

Published on 23 August 2024

The challenge for drug shortage: lessons learned from the quality issues of Japanese generic drug companies

Abstract:This paper examines the repercussions of recent quality and regulatory crises in Japan’s generic pharmaceutical sector, focusing on incidents involving Sawai Group Holdings (Sawai GHD) and other manufacturers. It provides...

Author(s): Takanao Hashimoto, PhD, Akihiko Ozaki, MD, PhD, Hiroaki Saito, MD, Erika Yamashita, Tetsuya Tanimoto, MD, Professor Mihajlo (Michael) Jakovljevic, MD, PhD, MAE

COVID-19 pandemic, drug shortages, generic drugs, good manufacturing practice, pharmaceutical policy

DOI: 10.5639/gabij.2024.1303.036

1.694 views

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Perspective

Published on 21 August 2024

US interchangeability designation: are we ready to cut the Gordian knot?

Abstract:US Food and Drug Administration’s (FDA) current thinking on interchangeability has evolved since the legal designation was first created in 2010. Based on experience, FDA now acknowledges that clinical switching...

Author(s): Gillian R Woollett, MA, DPhil, Joseph P Park, PhD

biosimilars, BPCIA, interchangeability, market exclusivity, quality, switching

DOI: 10.5639/gabij.2024.1303.035

2.623 views

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Review Article

Published on 18 November 2024

A review of international initiatives on pharmaceutical regulatory reliance and recognition

Abstract: In light of recent global health challenges, the need for regulatory reliance – where one regulatory authority accepts the decisions of another – has gained significant interest and momentum....

Author(s): Vimal Sachdeva, MSc

authorization, best practice, harmonization, pharmaceuticals, recognition

DOI: 10.5639/gabij.2024.1303.034

2.041 views

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Review Article

Published on 30 July 2024

Aligning environmental, social, and governance to clinical development: moving towards more sustainable clinical trials

Abstract:Drug development is among the highest producers of greenhouse gas (GHG) emissions, with about 4.4%–4.6% of the worldwide GHG emissions coming from the thousands of clinical trials being carried out...

Author(s): Shivani Mittra, MPharm, PhD, Shylashree Baraskar, MBBS, Elena Wolff-Holz, MD, Sandeep N Athalye, MBBS, MD

biological, biosimilars, carbon footprint, clinical trials, ESG (Environmental Social Governance), sustainability

DOI: 10.5639/gabij.2024.1303.033

1.937 views

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Editor's Letter

Published on 15 December 2024

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...

Author(s): Robin Thorpe, PhD, FRCPath

DOI: 10.5639/gabij.2024.1303.032

435 views

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Special Report

Published on 11 September 2024

Physicochemical stability of Fludarabine Accord in punctured original vials and after dilution with 0.9% sodium chloride solution

Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To assess the physicochemical stability of fludarabine in punctured original vials and after...

concentrated solution, diluted infusion solution, fludarabine, HPLC, physicochemical stability

DOI: 10.5639/gabij.2024.1302.031

646 views

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