Biosimilars in oncology: beyond regulation—building confidence through evidence and dialogue
Published on 27 October 2025
Generics and Biosimilars Initiative Journal (GaBI Journal). 2025;14(3).
Abstract: |
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, and economic advantages, achieved only limited integration into oncology practice in Chile? Their work, combining qualitative interviews with a value-chain approach, offers a rare and much-needed insight into the complex ecosystem shaping biosimilar adoption in the region.
Just as Professor Astier once emphasized that ‘the problem with biosimilars well evaluated is not their quality, but their acceptability’ [2], this Chilean study confirms that the barriers are no longer scientific but cultural, institutional, and communicational.
From regulation to confidence
The authors reveal that Chile’s regulatory framework (Norm N° 170) remains obsolete and focused primarily on safety equivalence rather than on interchangeability or structured switching. This gap mirrrs the European discussions that preceded the European Medicines Agency’s (EMA) current guidance on interchangeability.
Physicians in Chile continue to associate biosimilars with generics and to perceive them as lower-quality alternatives, while patients link cost reduction with poorer care. The study highlights the importance of trust—a variable that cannot be legislated but must be cultivated through transparency, education, and robust communication.
Their interviews also underscore a structural weakness common in Latin America: the lack of health technology assessment (HTA) and cost-effectiveness data for biosimilars. Without credible national figures on savings and access expansion, decision-makers remain hesitant, and physicians continue to rely on anecdotal impressions.
Education, evidence, and engagement
The five-dimensional roadmap proposed— scientific evidence, medical education, economic evidence, stakeholder engagement, and communication—resonates strongly with recent American Society of Clinical Oncology (ASCO) [3] and World Health Organization (WHO) recommendations. It provides a practical guide to move from theoretical equivalence to clinical confidence.
However, as the authors note, isolated educational campaigns are insufficient. Effective adoption requires synergistic action across regulators, payers, industry, and patient associations. Real-world registries, pilot programmes for switching, and accessible comparative data are indispensable tools for consolidating evidence and overcoming the ‘nocebo’ effect that still surrounds biosimilars in oncology.
International experiences confirm that physicians are more willing to initiate biosimilars in treatment-naïve patients and that transparent post-marketing surveillance programmes improve adherence. Chile’s hospitals could leverage these lessons by adopting a phased approach, beginning with supportive therapies and gradually advancing toward core oncological treatments.
Toward a new social contract
The editorial by Astier in 2020 argued that the comfort and local tolerance of biosi-milars, even when clinically minor, influen-ce patient acceptance and prescriber confidence [2]. Similarly, the Chilean case shows that the perceived experience of care—how the therapy is explained, administered, and monitored—matters as much as pharmacological comparability.
By redefining biosimilars as enablers of equity and sustainability rather than as cost-cutting substitutes, the work of Paredes and Lenz reframes the discussion in ethical and systemic terms. Biosimilars expand access to effective oncology treatments and create fiscal space for innovation—fulfilling what the authors call the ‘social contract’ of health systems.
Conclusion
This study stands as one of the most comprehensive analyses of biosimilar adoption barriers in Latin America. It highlights that evidence alone is not enough; trust, transparency, and coordinated action are equally essential. The roadmap proposed by the authors offers a realistic path for countries seeking to reconcile efficiency with equity in cancer care [1].
Competing interests: The author declares no conflicts of interest.
Provenance and peer review: Commissioned; internally peer reviewed.
References
1. Paredes-Fernández D, Lenz-Alcayaga RC. Barriers to expanding biosimilars in oncological indications in Chile: A value-chain approach to understand visions and propose recommendations for improving value proposition. Generics and Biosimilars Initiative Journal (GaBI Journal). 2025;14(3):XX-XX. doi:10.5639/gabij.2025.1403.0XX
2. Astier A. Is local tolerance of injectable biosimilars underestimated? Generics and Biosimilars Initiative Journal (GaBI Journal). 2020;9(4):149. doi:10.5639/gabij.2020.0904.024
3. Rodríguez G, Mancuso J, Lyman GH, Cardoso F, Nahleh Z, Vose JM, et al. ASCO policy statement on biosimilar and interchangeable products in oncology. JCO Oncol Pract. 2023;19(7):411-9.
Author: Professor César Humberto Oyarzo Mansilla, MEcon, Director of Continuing Education, Instituto de Salud Pública – Universidad Andrés Bello, Sazié 2320, Santiago Centro, Región Metropolitana, 8370146, Chile |
Disclosure of Conflict of Interest Statement is available upon request.
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