Review Article

Published on 04 May 2026

Bridging the global health equity gap: the impact of local biological manufacturing on patient access in Iran

Introduction/Study Objectives: Biological therapies have revolutionized the treatment of cancers, autoimmune, and metabolic diseases. However, access to these life-saving treatments remains severely limited in low- and middle-income countries due to high costs and infrastructure deficits. This study evaluates the impact of local manufacturing of biosimilars and complex biologicals on patient access in Iran, a lower-middle-income…

Author(s): Soheil Roshanzamiri, PharmD, Deyhim Atarod, PhD, Elmira Sayari, PharmD

access to medicines, biopharmaceutical manufacturing, biosimilars, health gain, Iran, pharmacoeconomics

DOI: 10.5639/gabij.2026.1502.

Special Report

Published on 24 March 2026

Budget impact analysis of implementation of biosimilars in a private health insurance company of large size in Southern Brazil 

Study objectives: To evaluate the budget impact of implementing a physician-led biosimilar switching programme within a large private health insurance company in Southern Brazil. Methods: This retrospective observational study analysed real-world data from a private payer perspective over 24 months (November 2022–October 2024). Six biologicals were included: infliximab, adalimumab, etanercept, rituximab, trastuzumab, and bevacizumab. In year…

Author(s): Rafael Gama, MD, MBA, Associate Professor Valderilio Feijó Azevedo, MSc, MD, PhD, Paula Heberle, MBA, Sergio Mauricio Menoncin, MSc, Daniela Toigo, MBA, Fabiana Aguiar, PG, Josymar Nascimento Júnior, MD, Ana Carolina Maciel, PG, Ricardo Luiz Pereira Bueno, BA, MHA, PhD

DOI: 10.5639/gabij.2026.1501.

Original Research

Published on 23 March 2026

Real-world evaluation of dosing and haemoglobin A1c (HbA1c) in patients converted from insulin glargine (Lantus®) to insulin glargine (Basaglar®) in Saudi Arabia 

Introduction/Study objective: About 28% of Saudi Arabia population above 15 years old are diagnosed with diabetes. Basal insulin glargine Lantus and its’ biosimilar Basaglar, are long-acting insulin that regulate blood glucose levels over 24 hours. Patients switch between basal insulins for various reasons including adverse events, availability and cost. Switching should be done with careful…

Author(s): Salwa Almomen, MD, MSc, Fares Alrubaish, PharmD, Radwan Hafiz, PharmD, Ali M Alhomaidan, PhD

biosimilars, HbA1c, interchangeability, long-acting insulin analogues, switching, treatment conversion

DOI: 10.5639/gabij.2026.1501.

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.

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.

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

Editor's Letter

Published on 15 December 2025

New research in biosimilars: oncology barriers, PFS handling, and Australian policy

In this third issue of 2025, we have pub- lications which include two editorials and three original research papers. All are in the biosimilars area and once more we have no papers dealing with generics. We strongly encourage potential authors of manuscripts in the generics field as well as those on biosimilars to submit them…

Author(s): Robin Thorpe, PhD, FRCPath

DOI: 10.5639/gabij.2025.1403.012

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 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

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

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