A spectrum of generics and biosimilars: research, reports, and interviews
Published on 2025/08/10
Generics and Biosimilars Initiative Journal (GaBI Journal). 2025;14(2):39.
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 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’ by Katherine Bouyer Sáez and Francisco Fuentes Poblete. For this a phase I, open- label, randomized, two-period, two-treat- ment (2×2) crossover study was carried out in fasting adult participants. The study showed that therapeutic bioequivalence was demonstrated between the new generic formulation (Dipemina) and the reference product Daflon.
This is followed by a Special Report titled ‘Follow-on biologicals/biosimilars approved in Brazil: September 2025 update by Sílvia Helena Cestari de Oliveira and Dr German Enrique Wassermann. This is a follow-on article, updating the information included in previous article [1] published in GaBI Journal. The report states that by September 2025, ANVISA (National Health Surveillance Agency, Agência Nacional de Vigilância Sanitária), the medicines regulatory author- ity in Brazil, had approved 67 biosimilars, although some of these are not real bio-similars as defined by the World Health Organization (WHO), It includes infor- mation on the regulatory framework for approval of biosimilars in Brazil and ter- minologies used for the different types of biological product which can be considered for approval in the country. It also has two substantial tables listing active substances and therapeutic areas of approved follow-on biologicals/biosimilars in Brazil and ANVISA approved follow-on biologicals/biosimilars.
Next is a Meeting Report on an online symposium hosted by the University of Helsinki on ‘Current trends in biosimilar uptake and special focus on automatic substitution’ by Lyles A, Heinonen E, Tolonen HM, Linden K, Sihvo S, Sarnola K and Airaksinen M. The symposium was focused on issues with biosimilars in Finland. This provided an overview of global trends in biosimilar use and a systematic examination of the implications of automatic substitution for diverse stakeholders. The progress of automatic substitution implementation will be continuously evaluated by research using, e.g. registers and safety incident reports. These can indicate needs for systemic changes in the substitution process to manage risks and optimize the process. The symposium proceedings, along with relevant updates, are presented in this report.
This is followed by an Interview with an Hasan Zeytin who is company CEO of Yerlika Biopharma in Turkey. The interview titled ‘Turkey’s biotech manufacturing ambitions: Yerlika Biopharma’s strategic role’ highlighted the company’s strategic focus which 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 its global presence. Yerlika specializes in developing and producing biologicals, including biosimilars, monoclonal antibodies, gene therapies, and vaccines.
A Sponsored Article ‘Biosimilar trial failed? Investors get their money back: a new insurance model redefines clinical trial financing’ by Tomas J Philipson, Dhruva Gupta, Jacob Shia and Rahul Gupta completes this issue of the journal. This describes a new, insurance-backed financing model for biosimilars which covers clinical trial costs if they fail. This reduces risk, improves capital access, and minimizes equity dilution for developers.
GaBI Journal has now been published for 14 years and is now clearly established as a leading peer reviewed, open access journal in the generics/biosimilars area. We encourage potential authors to submit high quality, relevant papers to the journal for consideration for publication.
Robin Thorpe, PhD, FRCPath
Editor-in-Chief, GaBIJournal
References
1. Cestari de Oliveira SH. Follow-on biologicals/ biosimilars approved in Brazil: May 2023 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2023;12(2):67-72. doi:10.5639/ gabij.2023.1202.012
Disclosure of Conflict of Interest Statement is available upon request.
Copyright © 2025 Pro Pharma Communications International
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
