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 glass vials, in polypropylene (PP) syringes, and after dilution with 0.9% sodium chloride solution or 5% glucose solution in polyolefine (PO) bags at different concentrations…

concentrated solution, diluted infusion solution, irinotecan, physicochemical stability

DOI: 10.5639/gabij.2024.1302.016

The editors and publisher wish to express their gratitude to the colleagues listed below for their valuable contribution to the peer review process for the Generics and Biosimilars Initiative Journal (GaBI Journal) in 2021. Dr Chiann Chang, Brazil Associate Professor Dr Devrim Demir Dora, Turkey Dr Thijs J Giezen, The Netherlands Dr Weng Fai Lai, Singapore Dr…

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 and polypropylene syringes as well as after dilution with water for injection (WFI) in polyolefine (PO) bags at three different concentrations (0.1 mg/mL, 0.62 mg/mL,…

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

DOI: 10.5639/gabij.2024.1302.013

Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of Vinorelbine Accord in original vials after first puncture and after dilution to concentrations between 0.1 mg/mL and 3.0 mg/mL in commonly used infusion fluids and containers. Methods: Test solutions were prepared aseptically,…

HPLC, physicochemical stability, vinorelbine

DOI: 10.5639/gabij.2024.1302.019

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 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…

Author(s): GaBI Journal Editor

biopharma, biopharmaceutical, biosimilars, biotech, Turkey

DOI: 10.5639/gabij.2025.1402.010

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 diluted infusion solutions was examined under various storage conditions. Pemetrexed Accord 25 mg/mL remained physicochemically stable for 28 days when stored protected from light in…

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

DOI: 10.5639/gabij.2024.1302.030

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 McKibben are not scientifically substantiated. Comment on ‘Misinformation about interchangeable biosimilars undermines US health policy, physician confidence, and patient health’ (GaBI Journal, 2024;13(2):55-60) Dear Editor,…

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

Letters to the Editor

Published on 18 December 2024

Comment on the article by Reilly MS and McKibbin RD

Abstract: Reilly and McKibbin oppose the update of FDA interchangeability guidance that does not require clinical switch studies. However, their arguments lack a scientific basis. Comment on the article by Reilly MS and McKibbin RD: Misinformation about interchangeable biosimilars undermines US health policy, physician confidence, and patient health.GaBI Journal, 2024;13(2):55-60. The US Food and Drug…

Author(s): Adjunct Professor Pekka Kurki, MD, PhD

interchangeable biosimilar, misinformation, switch studies

DOI: 10.5639/gabij.2025.1401.002

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 0.9% sodium chloride solution or 5% glucose solution in non-PVC and polyolefine (PO) bags to three different concentrations (0.025 mg/mL, 0.1 mg/mL, 0.5 mg/mL) and…

diluted infusion solution, HPLC, physicochemical stability, topotecan

DOI: 10.5639/gabij.2024.1302.017

Special Report

Published on 06 October 2025

Follow-on biologicals/biosimilars approved in Brazil: September 2025 update

Abstract: In Brazil, the legal framework for approving biosimilars was established in 2010 and the first biosimilar product was approved in 2015. In June 2024, RDC 875 introduced new provisions, including the use of international reference drugs and the possibility of waiving non-clinical and comparative clinical studies under certain conditions. By September 2025, ANVISA had…

Author(s): German Enrique Wassermann, PhD, Sílvia Helena Cestari de Oliveira, MSc

biosimilars, Brazil, clinical studies, regulatory framework

DOI: 10.5639/gabij.2025.1402.008

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 chloride infusion solution to concentrations of 0.1 mg/mL and 0.6 mg/mL in polyolefine (PO) bags. Methods: Test solutions were aseptically prepared and stored light protected…

diluted infusion solution, HPLC, mitoxantrone, physicochemical stability

DOI: 10.5639/gabij.2024.1302.014

Opinion

Published on 12 January 2026

Biosimilars: still safe, still effective, still not generics. Why is FDA suddenly pretending they are?

Abstract:The US Health and Human Services (HHS) and the US Food and Drug Administration’s (FDA) new initiative to ‘genericize’ biosimilars by fast-tracking approvals and eliminating key clinical and switching studies represents a radical departure from established global regulatory science. This policy dismisses the foundational distinction between complex biologicals and simple generic drugs—a distinction unanimously upheld by international regulators like…

Author(s): Michael S Reilly, Esq, Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP, Andrew Spiegel, Esq

biosimilars, FDA guidelines, genericization of biosimilars, interchangeable biosimilar, pharmacy substitution, totality of evidence

DOI: 10.5639/gabij.2026.1501.