Volume 14
2025
Issue 2
Highlights in this issue:
- 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
- Follow-on biologicals/biosimilars approved in Brazil: September 2025 update
- Current trends in biosimilar uptake and special focus on automatic substitution – a symposium report
126 views
Special Report – Stability Studies
The extended stability studies of anticancer therapies published in 2024 cover 21 small molecules across 10 parenteral drug groups in oncology.
Submit your Research
Practitioners in the scientific research area on the development and use of generics and biosimilar medicines who would like to author papers on related topics, and whose manuscripts comply with the editorial policy of GaBI Journal, are welcome to submit their manuscripts for assessment, peer review and publication in GaBI Journal.
For Authors
All articles are published electronically ahead of print with the definite citation line. Thus, an article will be available online shortly after the author’s approval to print.
Peer Review
All manuscripts submitted to GaBI Journal are subject to a rigorous peer review process.
We welcome suggestions for referees from the author though these recommendations may or may not be used. Names, postal and email addresses of three to four experts in the appropriate area of research should accompany each manuscript submission.
Article Processing Charges
The article will be published online after receipt of the corrected proofs. This is the official first publication citable with the DOI. After release of the printed version, the article can also be cited by issue and page numbers.
About GaBI
Sustainability and equal access to health care for all is at risk due to rapidly increasing costs. The reasons for this are diverse: increased standard of living and life expectancy, but also the high cost of new drug innovations. Today’s society is looking for inexpensive solutions to its ever-increasing demands. Healthcare systems endeavour on the one hand to provide groundbreaking, novel solutions to a greater than ever demand for therapeutic assistance, and on the other hand to achieve this in the most cost-efficient way.
Articles
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
99 views
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
149 views
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
76 views
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
28 views
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
83 views
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
235 views
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
321 views
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
438 views
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 […]
16 views
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 […]
666 views
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