Original Research

Published on 2026-02-03

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

Aim: 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 (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 FDA draft […]

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

Original Research

Published on 2025-12-15

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 […]

Chad Rieger, Clint Holland

Opinion

Published on 2025-12-04

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 the […]

Michael S Reilly, Esq, Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP, Andrew Spiegel, Esq

Original Research

Published on 2025-11-10

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 […]

Silvia Cirillo, PhD, Riken Soni, MPharm, Masna Rai, PhD, Steffen Leutz, PhD , Eveline Schurink, MD, Fausto Berti, PharmD, PhD

Original Research

Published on 2025-10-27

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 […]

Associate Professor Daniela Maria Paredes-Fernández, RM, MPH, Associate Professor Rony Christian Lenz- Alcayaga, MA 

Editorial

Published on 2025-10-27

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, […]

Professor César Humberto Oyarzo Mansilla, MEcon

Editorial

Published on 2025-10-20

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, […]

Adjunct Professor Pekka Kurki, MD, PhD

Sponsored Article

Published on 2025-10-10

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 […]

Tomas J Philipson, PhD, Dhruva Gupta, MD, Jacob Shia, MBA, Rahul Gupta, MD, MPH, MBA, FACP

Original Research

Published on 2025-10-07

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 (2×2) crossover study was carried […]

Katherine Bouyer Sáez, Francisco Fuentes Poblete

Special Report

Published on 2025-10-06

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 […]

German Enrique Wassermann, PhD, Sílvia Helena Cestari de Oliveira, MSc

Editor’s Letter

Published on 2025-08-10

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 report, one meeting report, one interview and one sponsored article.  The first article in this issue is an Original Research paper titled ‘Therapeutic equivalence of […]

Robin Thorpe, PhD, FRCPath

Interview

Published on 2025-04-15

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 […]

GaBI Journal Editor

Meeting Report

Published on 2025-04-14

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 of automatic substitution […]

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

Editor’s Letter

Published on 2025-04-10

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 […]

Robin Thorpe, PhD, FRCPath

Original Research

Published on 2025-04-08

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 […]

Peter Schneider, MA, Alexander Guggenberger, BSc, MSc, Siegfried Eisenberg, BSc, MSc, PhD, Lukas Rainer, BSc, MSc

Meeting Report

Published on 2025-04-07

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 […]

Michael S Reilly, Esq, Ralph D McKibbin, MD, FACP, FACG, AGAF, Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP, Andrew Spiegel, Esq

Letters to the Editor

Published on 2025-01-17

Comment on the article ‘Misinformation about interchangeable biosimilars’

Abstract:  The critique of Reilly and McKibben of the meta-analysis conducted by Herndon et al. is factually flawed on several important points. As a result, the conclusions of Reilly and McKibben are not scientifically substantiated. Comment on ‘Misinformation about interchangeable biosimilars undermines US health policy, physician confidence, and patient health’ (GaBI Journal, 2024;13(2):55-60) Dear Editor, […]

Hillel P Cohen, PhD, Caridad Pontes, MD, PhD, Fernando de Mora, MBA, PhD

Letters to the Editor

Published on 2024-12-18

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 […]

Adjunct Professor Pekka Kurki, MD, PhD

Editor’s Letter

Published on 2024-12-15

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 […]

Robin Thorpe, PhD, FRCPath

Review Article

Published on 2024-12-05

A review of international initiatives on pharmaceutical regulatory reliance and recognition

Abstract: In light of recent global health challenges, the need for regulatory reliance – where one regulatory authority accepts the decisions of another – has gained significant interest and momentum. A fundamental role of any government is to protect its citizens and promote a healthy lifestyle by ensuring the quality, safety, and efficacy of medical […]

Vimal Sachdeva, MSc

Interview

Published on 2024-10-31

Transforming health care: CinnaGen’s leadership in follow-on biologicals/biosimilars development and market expansion

Abstract: CinnaGen, the largest biopharmaceutical company in the MENA region, is a leader in developing follow-on biologicals/biosimilars. Dr Haleh Hamedifar, Chairperson of CinnaGen, spoke to GaBI (Generics and Biosimilars Initiative) about the company’s strategic focus, which includes expanding its product portfolio, entering highly regulated global markets, and advancing affordable treatments for conditions such as multiple […]

GaBI Journal Editor

Special Report

Published on 2024-09-11

Physicochemical stability of Azacitidine Accord 25 mg/mL suspension for injection in original vials and polypropylene syringes after reconstitution with refrigerated water for injection

Abstract: The physicochemical stability of Azacitidine Accord, a pyrimidine analogue antineoplastic agent, was assessed after reconstitution with cold water for injection (WFI) and storage in original glass vials and polypropylene (PP) syringes at different temperatures. At 2°C–8°C, stability was observed for 3 days in both containers. At -20°C, stability was maintained for 60 days regardless […]

Irene Krämer, PhD, Frank Erdnuess, PhD, Judith Thiesen, PhD

Special Report

Published on 2024-09-11

Physicochemical stability of Bortezomib Accord 2.5 mg/mL and diluted 1 mg/mL intravenous injection solution in punctured original vials and polypropylene syringes

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 polypropylene syringes under light-protected conditions at […]

Special Report

Published on 2024-09-11

Physicochemical stability of Cabazitaxel Accord in punctured original vials and after dilution with 0.9% sodium chloride or 5% glucose solution in non-PVC bottles

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 […]

Special Report

Published on 2024-09-11

Physicochemical stability of Carboplatin Accord in punctured original vials, syringes and after dilution with 0.9% sodium chloride or 5% glucose solution

Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of undiluted Carboplatin Accord 10 mg/mL in punctured original vials and polypropylene (PP) syringes as well as after dilution with commonly used infusion fluids in polyethylene (PE) bottles at two different concentrations (0.3 […]