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 for the journal. We have seen a very considerable variety of papers submitted and published during 2024. The first Review Article in this issue by…

Author(s): Robin Thorpe, PhD, FRCPath

DOI: 10.5639/gabij.2024.1303.032

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 prices of such medicines are shaped by regulations onpharmaceutical pricing, or the policy of setting the price of a medicine at certain points in 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

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

Sponsored Article

Published on 10 October 2025

Biosimilar trial failed? Investors get their money back: a new insurance model redefines clinical trial financing

Abstract: A new insurance-backed financing model for biosimilars uses AI-powered underwriting to cover clinical trial costs if they fail. This reduces risk, improves capital access, and minimizes equity dilution for developers. Introduction Developing biosimilars has always involved a complex calculus of risk, capital, and time. Now, a newly launched insurance-backed financing model could dramatically change…

Author(s): Tomas J Philipson, PhD, Dhruva Gupta, MD, Jacob Shia, MBA, Rahul Gupta, MD, MPH, MBA, FACP

AI underwriting, biosimilars, clinical trial insurance, drug development financing, non-dilutive capital, risk management

DOI: 10.5639/gabij.2025.1402.011

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.

Original Research

Published on 10 November 2025

Effective and safe handling of pre-filled syringe (PFS) for administration of biosimilar candidate AVT06 (aflibercept) in patients with chorioretinal vascular diseases

Introduction: Chorioretinal vascular diseases are among the leading causes of irreversible blindness in industrialized countries. The prognosis of chorioretinal vascular diseases has been largely improved with the introduction of the vascular endothelial growth factor (VEGF) inhibitors, biological drugs which have become the first line therapy for patients with these conditions. The development of biosimilars may…

Author(s): Silvia Cirillo, PhD, Riken Soni, MPharm, Masna Rai, PhD, Steffen Leutz, PhD, Eveline Schurink, MD, Fausto Berti, PharmD, PhD

aflibercept, AVT06, biosimilar, chorioretinal disease, Eylea, PFS

DOI: 10.5639/gabij.2025.1403.016

Original Research

Published on 27 October 2025

Barriers to expanding biosimilars in oncological indications in Chile: A value-chain approach to understand visions and propose recommendations for improving value proposition

Introduction and Study Objectives: Despite their well-established potential to reduce healthcare expenditures, biosimilars have not achieved widespread adoption in Chile, particularly in oncology. The lack of regulatory incentives and reimbursement frameworks only partially explains this phenomenon. This study aims to identify key barriers to biosimilar adoption in the Chilean healthcare system and propose strategic recommendations…

Author(s): Associate Professor Daniela Maria Paredes-Fernández, RM, MPH, Associate Professor Rony Christian Lenz-Alcayaga, MA 

access barriers, biological medicines, biosimilar pharmaceuticals, healthcare financing, oncology

DOI: 10.5639/gabij.2025.1403.015

Editorial

Published on 20 October 2025

Rising costs of biologicals: effective cost-containment does not please all stakeholders

Abstract: Rieger and Holland provided a report of a stakeholder meeting dealing with the biosimilar uptake in Australia. The proposed policy measures reported may not have a dramatic effect on the biosimilar uptake. From the scientific and medical point of view, the biotech industry has developed wonderful medicines for treating chronic and life-threatening diseases. Unfortunately,…

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

biosimilars, cost containment, health professionals, substitution, tender

DOI: 10.5639/gabij.2025.1403.014

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 patent expiry and a meeting report on claimed weakening of FDA regulatory standards for biosimilars and its perceived effects on undermining physician confidence in biosimilar…

Author(s): Robin Thorpe, PhD, FRCPath

DOI: 10.5639/gabij.2025.1401.001

Original Research

Published on 15 December 2025

Australian biosimilar policies not delivering on intended outcomes: where to from here?

Introduction/Background: Biosimilar medicines represent an opportunity to expand access to medicines and reduce costs for payers through increased uptake. Australia is not fully capitalising on this opportunity relative to other Organisation for Economic Co-operation and Development (OECD) countries, reflected in comparisons of biosimilar medicines uptake by other OECD countries. Understanding of international examples can help to…

Author(s): Chad Rieger, MBA, BSc Pharm, Clint Holland

Australia, biosimilars, drivers, government strategies, policy, uptake

DOI: 10.5639/gabij.2025.1403.017

Original Research

Published on 16 December 2025

A bioequivalence study of paliperidone palmitate once-monthly (156 mg/mL) extended-release injectable in patients with schizophrenia 

Study objective: To evaluate the steady-state pharmacokinetic bioequivalence of Mylan’s paliperidone palmitate extended-release injectable suspension 156 mg/mL (test formulation) with Janssen’s Invega Sustenna (R) (paliperidone palmitate) extended-release injectable suspension 156 mg/mL (reference formulation), in patients with schizophrenia, and to evaluate the safety and tolerability of the test formulation. Methods: The study was designed based on the…

Author(s): Ofer Agid, MD, J Christopher Gorski, PhD, Mark Shiyao Liu, MS, Prasanna C Ganapathi, MD, Mohna Mukund Toro, MD, Pradeep Purushottamahanti, MBBS, MBA

bioequivalence, long-acting injectable antipsychotic, paliperidone palmitate, pharmacokinetics, schizophrenia

DOI: 10.5639/gabij.2026.1501.

Editorial

Published on 27 October 2025

Biosimilars in oncology: beyond regulation—building confidence through evidence and dialogue

Abstract: This editorial discusses systemic barriers limiting oncology biosimilar adoption in Chile and Latin America, emphasizing trust, education, and coordinated policy actions to strengthen value, equity, and confidence in biosimilars. The manuscript by Paredes-Fernández and Lenz-Alcayaga [1] addresses a key but often neglected question in Latin America: why have biosimilars, despite their proven safety, efficacy,…

Author(s): Professor César Humberto Oyarzo Mansilla, MEcon

biosimilars, Chile, education, oncology, public policy, social trust

DOI: 10.5639/gabij.2025.1403.013