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Exploring the barriers to biosimilar adoption in Chile
In Chile, biosimilars uptake is limited, especially for oncology biosimilars. A new study published in GaBI Journal [1] identifies the key barriers to biosimilar adoption in Chile and proposes strategic recommendations to strengthen their value proposition.
Projections suggest that switching only four high-cost drugs could save more than US$26 million annually in Chile and expand patient access. However, despite having a biosimilar pathway established in 2014 (Norm N°170), no regulatory measures are in place to promote their adoption and reimbursement.
Oncology biosimilars are particularly poorly represented in the Chilean biosimilar market. According to data from the Public Health Institute of Chile, of the 34 approved biosimilars, only eight are used in oncology –seven as core therapies and one as supportive treatment (filgrastim).
Now, in this recent study, the authors have mapped the barriers across the healthcare value chain and identified strategies to strengthen the biosimilar value proposition in Chile.
Eight strategic activities in the pharmaceutical sector were explored using Michael Porter's value chain strategic framework, which breaks down a company’s activities into primary and support functions to identify sources of competitive advantage and create value for customers. The strategic activities were regulatory approval, local approval, health technology assessment (HTA), financial coverage, medical education, prescription, purchasing, and adherence. Additionally, they carried out 19 in-depth interviews with hospital-based professionals, patients, and policymakers using semi-structured and convergent techniques. The authors found that, at each stage, barriers limit uptake, particularly in oncology.
In general, interviewees agreed that initiating biosimilars in treatment-naïve patients is broadly accepted, however switching stable patients remains controversial due to unclear guidance, limited risk-management protocols, and strong physician autonomy. Patients often perceive switching as cost-driven rather than clinically justified. Additionally, Norm N°170 (2014) is widely viewed as outdated.
HTA processes recognize biosimilars’ clinical comparability and economic potential, yet they lack political priority. Physicians are not required to justify prescribing originators, and policymakers are hesitant to challenge specialist authority. Financially, stakeholders agree biosimilars could expand access and create fiscal space for innovation, but savings are rarely quantified or transparently communicated.
Medical education gaps are substantial. Confusion between generics and biosimilars persists, and misconceptions about manufacturing quality and safety remain common. Oncologists’ support is seen as critical, yet biosimilars are not central in scientific societies. Peer-led education, registries, and pilot programmes were recommended to build confidence.
At the prescription stage, physician reluctance stems from legal risk, conservative clinical culture, and lack of incentives. Patients often associate higher price with better quality and fear inferior outcomes in the public system. Concerns about adverse events and disease progression complicate adherence, especially in cancer care, where switching can increase anxiety and strain physician–patient trust.
Procurement and purchasing processes are fragmented, with multiple brands used simultaneously, creating administrative burdens and pharmacovigilance challenges. Evidence on budget impact and cost-effectiveness is limited, and biosimilar companies are perceived as competing mainly on price, unlike originators that offer broader institutional partnerships.
To address these barriers, the authors propose a five-dimensional roadmap: strengthen scientific evidence communication and switching guidelines; expand structured medical education; clarify and quantify economic value; improve stakeholder engagement; and enhance public positioning. They highlight that coordinated, multisectoral action is essential to unlock biosimilars’ potential to improve equity, sustainability, and access to oncology care in Chile.
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Reference
1. Paredes-Fernández DM, 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).75-84. doi:10.5639/gabij.2025.1403.015
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