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 Abstract: This study assessed the physicochemical stability of Bortezomib Accord 2.5 mg/mL solutions for subcutaneous and intravenous injection under various storage conditions. Bortezomib 2.5 mg/mL solutions for subcutaneous injection remained stable for up to 84 days in punctured vials and…

bortezomib, intravenous injection, physicochemical stability, subcutaneous injection

DOI: 10.5639/gabij.2024.1302.015

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

Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of undiluted Cabazitaxel Accord in punctured original vials and after dilution with 0.9% sodium chloride solution or 5% glucose solution in non-PVC bottles at the concentrations 0.1 mg/mL and 0.26 mg/mL. Methods: Punctured…

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

DOI: 10.5639/gabij.2024.1302.027

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

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 and the US Food and Drug Administration’s 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 the European…

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.2026.1501.004

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 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…

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

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

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

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

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…

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