Author(s): Michael Cohan

Innovator drug sourcing challenges

Editor's Letter

Published on 10 January 2024

Latest features in GaBI Journal, 2023, Issue 3

The articles in this issue of the GaBI ­Journal highlight two important issues that must be considered when reading scientific publications. The first two articles illustrate the rapidly expanding influence of non-US, non-European economies on the global pharmaceutical industry. The second two articles illustrate the need to carefully evaluate the role of any potential author…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2023.1203.012

Submitted: 4 November 2023; Revised: 24 November 2023; Accepted: 27 November 2023; Published online first: 28 November 2023 A study by Meijboom et al. aimed to compare the risk of and reasons for infliximab discontinuation between retransitioned patients and those remaining on biosimilar [1]. When the market exclusivity of the originator infliximab (Remicade) expired in 2014,…

DOI: 10.5639/gabij.2023.1203.017

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 dilution with 0.9% sodium chloride solution at three different concentrations (0.25 mg/mL, 1.2 mg/mL, 6.0 mg/mL) in commonly used infusion containers. Methods: Test solutions were…

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

DOI: 10.5639/gabij.2024.1302.031

Contents Editor’s Letter The importance of trust Original Research Social trust and regional variation in the adoption of biosimilars in Italy and Germany US prescribers’ attitudes and perceptions about biosimilars Review Article Development of Ph. Eur. standards for therapeutic monoclonal antibodies: infliximab case study Meeting Report Key factors for successful uptake of biosimilars: Europe and the US

Original Research

Published on 07 October 2025

Therapeutic equivalence of a formulation of purified micronized flavonoid fraction of diosmin/hesperidin 450 mg/50 mg in healthy adults: an open-label, randomized, single-dose, crossover study

Introduction/Study objectives: Given that the purified micronized flavonoid fraction (diosmin/hesperidin 450 mg/50 mg) is a formulation with low water solubility, granulated form, and low intestinal membrane permeability, the present bioequivalence study was conducted to compare Dipemina® (T: tested) with Daflon® (R: reference product).Methods: A phase I, open-label, randomized, two-period, two-treatment (2x2) crossover study was carried…

Author(s): Katherine Bouyer Sáez, Francisco Fuentes Poblete

bioequivalence, diosmin/hesperidin, purified flavonoid fraction

DOI: 10.5639/gabij.2025.1402.007

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

Editor's Letter

Published on 11 July 2024

First 2024 GaBI Journal issue highlights

It was with great pleasure that I assumed the role of Editor-in-Chief (EiC) of GaBI Journal in January of this year. Taking over the helm from Professor Philip D Walson is a considerable challenge; Phil’s excellent, thorough example will be very difficult to follow. My experience is restricted largely to biosimilars with which I have…

Author(s): Robin Thorpe, PhD, FRCPath

DOI: 10.5639/gabij.2024.1301.001

Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of Epirubicin Accord 2 mg/mL concentrate in original glass vials after first opening and after transfer to polypropylene (PP) syringes as well as diluted Epirubicin Accord solutions 0.1 mg/mL, 1.6 mg/mL in 0.9%…

concentrated solution, diluted infusion solution, epirubicin, physicochemical stability

DOI: 10.5639/gabij.2024.1302.012

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 Special Focus on Automatic Substitution’. This provided an overview of global trends in biosimilar use and a systematic examination of the implications…

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

DOI: 10.5639/gabij.2025.1402.009

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

Contents Editor’s Letter What to look forward to in GaBI Journal, 2022, Issue 2 Commentary Substitution and interchangeability: time for a conversation? Original Research On statistical evaluation for interchangeability of biosimilar products A case study of AstraZeneca’s omeprazole/esomeprazole chiral switch strategy Review Article Manufacture and regulation of cell, tissue and gene therapy products: global perspectives,…