New research in biosimilars: oncology barriers, PFS handling, and Australian policy
Published on 2025/12/15
Generics and Biosimilars Initiative Journal (GaBI Journal). 2025;14(3):72.
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 to the journal for consideration for publication.
The issue commences with an Editorial titled ‘Biosimilars in oncology: beyond regulation—building confidence through evidence and dialogue’ authored by Pro- fessor César Humberto Oyarzo Mansilla of Instituto de Salud Pública—Universidad Andrés Bello, Santiago Central, Chile, which comments on the paper by Paredes- Fernández and Lenz-Alcayaga appearing in this issue (see page 75). This editorial discusses systemic barriers limiting oncol- ogy biosimilar adoption in Chile and Latin America, emphasizing trust, educa- tion, and coordinated policy actions to strengthen value, equity, and confidence in biosimilars.
The second Editorial, ‘Rising costs of bio- logicals: effective cost-containment does not please all stakeholders’, by Adjunct Professor Pekka Kurki, a regular contribu- tor to GaBI Journal, comments on a study by Rieger and Holland that included an interactive session with experts in the field. Their manuscript, ‘Pioneering access for patients through biosimilar medicines’, also appears in this issue of the journal (see page 93). Professor Kurki considers that the proposed policy measures reported during the stakeholder meeting—dealing with the biosimilar uptake in Australia— may not have a dramatic effect on the uptake of biosimilars in this country.
The first Original Research paper in this issue is titled ‘Barriers to expanding bio- similars in oncological indications in Chile: A value-chain approach to understand visions and propose recommendations for improving value proposition’, authored by Associate Professors Daniela Maria Paredes- Fernández and Rony Christian Lenz- Alcayaga of the Public Health Institute, Uni- versi dad Andrés Bello, Santiago, Chile. Despite the growing availability of robust evidence on the efficacy and benefits of biosimilars—including well-established potential to reduce healthcare expenditure and improve health equity—their adoption in Chile has been suboptimal. Norm N° 170, issued in 2014, establishes the regulatory framework for the registration of biotechno- logical products derived using recombinant DNA (rDNA) techniques in Chile. It defines a biosimilar as a biotechnological drug that has demonstrated comparable quality, safety, and efficacy to the reference product. This regulation states that the approval of a biosimilar enables interchangeability or substitution if it follows a structured and stepwise process under strict medical supervision. This report aims to explore barriers to biosimilar adoption in onco- logical indications within the Chilean healthcare system and provides recommen- dations for improving value proposition in key dimensions.
The second Original Research paper, titled ‘Effective and safe handling of pre-filled syringe (PFS) for administration of bio- similar candidate AVT06 (aflibercept) in patients with chorioretinal vascular dis- eases,’ is by Drs Silvia Cirillo, Riken Soni, Masna Rai, Steffen Leutz, Eveline Schurink, and Fausto Berti from Alvotech Swiss AG, Zürich, Switzerland. They report that chorioretinal vascular diseases are among the leading causes of irreversible blindness in industrialized countries. Their study aims to demonstrate the effective and safe handling of AVT06 PFS when administered to study participants with chorioretinal vascular dis- eases. The primary objective was to evaluate the proportion of successful administrations of AVT06 after a single administration with PFS. The secondary objective of the study was to evaluate ocular safety after a single dose of AVT06 delivered with PFS.
The last Original Research paper in this issue is authored by Chad Rieger and Clint Holland of Sandoz Pty Ltd, Australia, and is titled ‘Australian biosimilar policies not delivering on intended outcomes: where to from here?’ They conclude from their study that, with increasing use of biological therapies on the hori- zon, Australia must learn from the suc- cessful strategies implemented in other countries to ease the growing burden of healthcare spending and ensure the sustainability of the Pharmaceutical Benefits Scheme.
Robin Thorpe, PhD, FRCPath
Editor-in-Chief, GaBIJournal
Disclosure of Conflict of Interest Statement is available upon request.
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