Articles

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...

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.

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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...

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.

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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...

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.

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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....

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

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

DOI: 10.5639/gabij.2025.1403.

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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...

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

biosimilars, cost containment, health professionals, substitution, tender

DOI: 10.5639/gabij.2025.1403.

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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...

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

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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...

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

bioequivalence, diosmin/hesperidin, purified flavonoid fraction

DOI: 10.5639/gabij.2025.1402.007

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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,...

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

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Editor's Letter

Published on 10 August 2025

A spectrum of generics and biosimilars: research, reports, and interviews

In this second issue of 2025, we have a diverse spectrum of publications which include one original research paper in the generics area and biosimilar-focused articles which comprise one special...

Author(s): Robin Thorpe, PhD, FRCPath

DOI: 10.5639/gabij.2025.1402.006

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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

DOI: 10.5639/gabij.2025.1402.010

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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

DOI: 10.5639/gabij.2025.1402.009

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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...

Author(s): Robin Thorpe, PhD, FRCPath

DOI: 10.5639/gabij.2025.1401.001

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