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

633 views

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Special Report

Published on 11 September 2024

Physicochemical stability of Pemetrexed Accord 25 mg/mL in punctured original vials and after dilution with 0.9% sodium chloride solution in non-PVC bottles

Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Abstract: In this study, the physicochemical stability of Pemetrexed Accord 25 mg/mL concentrate and its...

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

DOI: 10.5639/gabij.2024.1302.030

630 views

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Special Report

Published on 11 September 2024

Physicochemical stability of Irinotecan Accord in punctured original vials and polypropylene syringes and after dilution with 0.9% sodium chloride or 5% glucose solution in polyolefine bags

Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of undiluted Irinotecan Accord concentrate in punctured original...

concentrated solution, diluted infusion solution, irinotecan, physicochemical stability

DOI: 10.5639/gabij.2024.1302.016

612 views

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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

610 views

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Meeting Report

Published on 14 April 2025

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...

Author(s): 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

affordable medicines, automatic substitution, biological medicines, biosimilar, community pharmacy, Finland

601 views

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Special Report

Published on 11 September 2024

Physicochemical stability of Idarubicin Accord in punctured original vials, syringes and after dilution with water for injection

Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of undiluted Idarubicin Accord in punctured original vials...

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

DOI: 10.5639/gabij.2024.1302.013

600 views

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Special Report

Published on 11 September 2024

Physicochemical stability of Topotecan Accord after dilution with 0.9% sodium chloride or 5% glucose solution in polyolefine and non-PVC bags

Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of Topotecan Accord 1 mg/mL concentrate diluted with...

diluted infusion solution, HPLC, physicochemical stability, topotecan

DOI: 10.5639/gabij.2024.1302.017

527 views

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Special Report

Published on 11 September 2024

Physicochemical stability of Mitoxantrone Accord after dilution with 0.9% sodium chloride solution in polyolefine bags

Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To assess the physicochemical stability of Mitoxantrone Accord after dilution with 0.9% sodium...

diluted infusion solution, HPLC, mitoxantrone, physicochemical stability

DOI: 10.5639/gabij.2024.1302.014

505 views

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Interview

Published on 15 April 2025

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...

Author(s): GaBI Journal Editor

biopharma, biopharmaceutical, biosimilars, biotech, Turkey

500 views

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Editor's Letter

Published on 10 September 2024

What to look forward to in GaBI Journal, 2024, Issue 2

Issue 2 of Volume 13 of GaBI ­Journal starts with a Review Article by Paul et al., titled ‘Increasing adoption of quality-assured biosimilars to address access challenges in low- and middle-income...

Author(s): Robin Thorpe, PhD, FRCPath

DOI: 10.5639/gabij.2024.1302.007

460 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

436 views

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