Barriers to expanding biosimilars in oncological indications in Chile: A value-chain approach to understand visions and propose recommendations for improving value proposition
Published on 27 October 2025
Generics and Biosimilars Initiative Journal (GaBI Journal). 2025;14(3).
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 to strengthen their value proposition. |
Introduction and study objectives
Despite the growing availability of robust evidence on the efficacy and benefits of biosimilars including well-established potential to reduce healthcare expenditure and to improve health equity, their adoption in Chile has been suboptimal. Although local estimates indicate that switching to biosimilars for just four drugs could yield annual savings exceeding 26 million dollars [1] and expand access to care for additional patients [2], no regulatory measures have been implemented to promote their adoption and reimbursement, either for treatment-naïve patients or for other populations.
The Norm N° 170, issued in 2014, establishes the regulatory framework for the sanitary registration of biotechnological products derived from recombinant DNA 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. It also states that interchangeability is a physician-driven decision based on risk-benefit assessment requiring patient awareness of the substitution [3].
Biosimilars seem better accepted in non-oncologic conditions in Chile, such as diabetes, Crohn’s disease, and ulcerative colitis [4], in contrast to their use in oncology. 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) [5].
International reports commonly find that healthcare providers lack familiarity with biosimilar concepts and supporting evidence [6–9]. Some authors explore bias and negative attitudes from practitioners and patients [10]. However, the problem preventing the penetration of biosimilars in Chile seems to be more complex. Our report aims to explore barriers to biosimilar adoption in oncological indications within the Chilean healthcare system and provides recommendations for improving value proposition in key dimensions.
Methods
Our analysis combines Michael Porter’s value chain as a main conceptual framework, with exploratory interviews on barriers and recommendations. The value chain enables the disaggregation of primary and support activities that strategically contribute to value creation [11]. This analysis will focus on identifying the primary strategic activities. This study defi nes value as improved patient access to oncology treatments using biosimilars and identifi es eight strategic activities that contribute to it.
Sequentially, we applied an in-depth barrier exploration interview method to explore barriers for each strategic activity, usually used in marketing studies [12]. A panel of nationally recognized key opinion leaders was consulted. A semi-structured in-depth [13] and convergent interviewing [14] process was conducted over 60 to 90 minutes. Participation was subject to prior informed consent. Interviews followed qualitative research standards, including triangulation, saturation, and narrative sufficiency. Individual interviews and homogeneous discussion groups were formed, including oncologists, oncology pharmacists, patients, and policymakers involved in procurement and insurance. After segmentation, a snowball mapping technique was applied to improve representation. All information provided was decoded, and participants were assigned an associated encryption to ensure anonymity.
Before each interview, Abbott’s role as the research funder was disclosed. Informed consent was obtained from all interviewees. In the case of public sector authorities, interviews were man- aged through the Lobby Law N° 20,730, ensuring traceability and public access to meeting content via online platform.
For data analysis, literal transcriptions were made of all inter- views, with unique identifiers to ensure confidentiality. Quotes were translated from the native language (Spanish) to English and subsequently back-translated to preserve their cross-cultural original meaning [15]. The verbatim technique was employed, and representative phrases refl ecting the saturated opinions of the consulted participants are presented. To minimize selection bias in the analysis, double coding was employed alongside maximum variation sampling, which involved the inclusion of stakeholders at various levels of health system governance, not limited to healthcare professionals only, and encompassing both positive and negative perspectives on the evaluated health technologies. The analysis incorporated emergent categories.
Results
The value chain was structured into eight primary strategic activities. The fi rst set of activities involves international and national regulatory approvals. Next is the health technology assessment, which evaluates clinical and economic evidence to inform fi nancial coverage decisions. Financial coverage includes reimbursement by payers and incorporation into health plans. Another key component is medical education, ensuring prescribers are informed and unbiased. The model then includes the prescription step, followed by procurement. Finally, patient adherence over time completes the process, as shown in Figure 1.
Figure 1: Value chain for biosimilars in Chile
Regulatory and local approval
Interviewees agreed that while initiating biosimilars in naïve patients faces few barriers, switching poses significant challenges, primarily regulatory. There was widespread agreement on the obsolescence of Norm N° 170 to support the integration of biosimilars.
Policymaker 6: “Today, the only real position is this norm from 10 years ago … but it’s a norm from 10 years ago, and the industry has changed a lot. The authority should say – look, there is a product that won the tender, all naïve patients will be assigned to the biosimilar, and continuity of treatment with originators will be maintained for exist- ing patients—that’s it”.
Hospital-based Professional 5: “The barriers to moving forward with biosimilars lie in the norm. Within the norm, the switch and the guidelines for the risk management program should be improved because they are very general. If you’re going to do the switch, you need to enhance the guidelines on how to follow it”.
Patient 3: “Patients have difficulties with interchangeability. There’s no conflict for naïve cases, but there are problems with the switch. Don’t just change drugs to people like that”.
Biosimilars are a relatively new and immature topic in Chile, especially regarding information and regulation. Patients acknowledge their therapeutic value but often perceive them only as a cost-reduction strategy.
Hospital-based Professional 1: “We are still getting to know biosimilars, and our scientific and regulatory understanding is at the same stage of maturity as it was with bioequivalents six years ago.”
Patient 4: “We know that access to biosimilars is part of the growth process, but patients shouldn’t have to reduce costs for the State. It feels like they are cutting costs”.
Health Technology Assessment
Although there is a preliminary approach at the ministerial level to promote the evaluation and adoption of biosimilars, it does not appear to be a priority on the agenda.
Policymaker 9: “There has been no regulatory update to limit the decision-making power of treating physicians, even when their decisions impact the entire system. Within the Ministry, there are no passionate or heated discussions about biosimilars”.
Some interviewees attribute this to a reluctance to challenge the preferences of specialists.
Policymaker 3: “This is all about political willingness to confront the major powers that remain in the hands of physicians”.
Policymaker 4: “Another approach would be to say— Doctors, once all product evaluations have been conducted and safety, efficacy, quality, and regulatory approval have been certified—interchangeability will be the rule, with exceptions allowed only for specific reasons and under your responsibility if the patient is to use the originator.—In other words, you invert the rule. Today, it’s the opposite: the rule says the doctor decides. It’s a real wall”.
Policymaker 9: “Doctors aren’t even required to justify the prescription choice (…). One viable path to promote change is for Norm° 170 to reduce the decision-making power of the physician or to establish some oversight body for that medical decision”.
Financial coverage
Policymakers unanimously recognized that biosimilars enhance access to high-cost drugs by lowering healthcare costs, underscoring their budgetary value.
Policymaker 2: “Biosimilars create budgetary room for innovations, particularly for cutting-edge technologies. They serve as an entry point and are part of the pharmaceutical lifecycle”.
Policymaker 3: “The sector should move toward greater biosimilar adoption. There is a lack of funding, and if strong arguments demonstrate that biosimilars are as effective and efficient as the originators, progress is necessary”.
Policymaker 4: “The biosimilar process is not anti-innovation; on the contrary, it legitimizes the model. It is part of the social contract—without it, that contract is broken”.
Medical education
Cultural factors among physicians affect biosimilar prescription, driven by concerns over treatment quality and persistent misconceptions in clinical and managerial settings.
Hospital-based Professional 2: “Within scientific societies, biosimilars are not a major topic. There are no clear usage guidelines or consensus, and the issue is simply not on the radar at the hospital level, I don’t think everyone understands what a biosimilar is. Even the hospital director, the administrative director, and the head of purchasing don’t understand what a biosimilar is. They think it’s the same, but cheaper”.
Policymaker 2: “Less information is available on reference biologics and biosimilars than chemically synthesized drugs. The only exception is vaccines. There are concerns and distrust. Addressing physicians’ reluctance to prescribe biosimilars depends on the robustness of the evidence demonstrating their efficacy, safety, and pharmacovigilance measures”.
Policymaker 3: “Physicians perceive differences in quality, which needs to be addressed with solid evidence. As a payor, I lacked the data to demonstrate to doctors that biosimilars were superior; all I had was the financial argument”.
Policymaker 4: “There’s still a significant lack of awareness about differences between generics, biosimilars, and biologics. Continuous education efforts are needed—for physicians, pharmacists, nurses, and other professionals—the misunderstanding remains high”.
Patient 3: “We’ve had several issues getting people to understand what a biologic is because it sounds like natural medicine, almost homeopathic”.
Biosimilar adoption is often viewed as ‘losing the battle’, with prestige attributed to those prescribing originators. Gaining oncologists’ support and involving them in education is seen as crucial.
Hospital-based Professional 4: “Among oncologists, there are two perspectives. One group recognizes that the number of patients needing treatment is increasing, and they have already lost the battle—they no longer care which drug is used as long as the patient receives biological treatments. The other group continues to resist and refuses to switch to a different biologic”.
Hospital-based Professional 2: “Education should start with oncologists, ensuring that biosimilars are presented properly— as molecules worthy of respect. Biosimilars are not mere copies. Oncologists need to be assured that they are not being deceived. If we fail to engage with them, they will continue to believe that biosimilars are nothing more than a chamomile tea”.
Hospital-based Professional 3: “One of the earliest misconceptions was equating bioequivalents with biosimilars. Many physicians are unaware that biosimilars are high-quality, scientifically validated alternatives”.
Patient 2: “Medical education should be peer-led. Physicians seek guidance from their key opinion leaders -essential for influencing clinical behavior. Ideally, they should be international experts who speak the same native language”.
Policymaker 6: “Switching to a biosimilar was seen as a disadvantage for patients because, in breast cancer, while one option takes only three minutes to administer, the other requires the patient to be connected to an infusion pump for an hour and a half. So, in many cases, it was not a decision that benefited patients—quite the opposite”.
Experts recommend using registries and pilots, emphasizing the need for synthesized, accessible evidence for clinicians and decision-makers.
Policymaker 3: “Mechanisms such as registries or laboratory-supported follow-up programs may improve access to biosimilars. Pilots have shown promising results”.
Policymaker 8: “Biosimilars technical validation should be presented in a more standardized and digestible format. Those reviewing this information are not necessarily clinicians nor specialists in bioequivalence or biosimilar regulations. A concise summary table outlining key approvals—such as the US Food and Drug Administration (FDA) recognition as a biosimilar—along with a one-page reference to supporting studies, would be highly beneficial”.
Interviewees stressed the need for continuous pharmacovigilance. They observed no differences in adverse reactions, noting equal surveillance protocols for both products.
Hospital-based Professional 4: “I’ve noticed that initially, I received more reports about pharmacovigilance, but now I’m no longer being informed of any issues, either with the reference drug or the biosimilar, for various brands. I see no difference between a reference drug and a biosimilar”.
Prescription
Patients associate equity with access to reference treatments, viewing public sector treatments as ‘alternatives’. Clinicians couple adverse events with strained physician-patient relationships, while advocacy groups report unauthorized switches.
Patient 2: “Patients have no idea what medication they are being given (…). Patients are sometimes threatened when they consider discontinuing treatment, being told that if they stop, they will not be able to return for further care. I remember objections from oncologists because patients with gastrointestinal stromal tumours were being treated with biosimilars and experiencing adverse reactions, which harmed the physician–patient relationship and led to numerous complaints. In many cases, I witnessed patients being left untreated until the adverse event subsided, leaving them anxious and uncertain. Additionally, we learned of unauthorized switches from originator drugs to biosimilars—decisions made at an administrative level rather than a clinical one”.
Patient 4: “The lack of equity in cancer treatment will ultimately reveal that the private sector provides originator drugs while the public sector offers alternatives.”
Key obstacles include physician reluctance due to a lack of incentives, legal or clinical risk concerns, and the absence of structured protocols for switching to biosimilars.
Policymaker 1: “Although the law allows new patients with conditions such as rheumatoid arthritis to initiate treatment with biosimilars, this has been met with complaints and petitions from patient advocacy groups urging us not to proceed. A common ethical question arises: If your parents were diagnosed with cancer, would you choose the originator drug or the biosimilar”?
Policymaker 3: “Physicians oppose biosimilars, much like they did with bioequivalent drugs, arguing that they do not produce the same results or response levels. They convince patients of this, leading them to reject the biosimilar”.
Hospital-based Professional 4: “Once the patient has interacted with a physician who expresses preferences, they internalize these concerns. Patients question whether the medication they receive is the ‘good one’ or not. There are significant communication issues, and patients believe that biosimilars are inferior because of the information they receive from doctors”.
Policymaker 4: “Why would a physician risk switching a patient’s treatment if the originator drug already works well? Financial concerns are not their responsibility. Doctors aim to protect themselves from lawsuits. A deeply ingrained conservative attitude is prevalent among physicians. Their focus is on patient risk rather than cost savings or expenditure efficiency. That is the core issue—physicians have no incentive to try something new. Even if a physician is well-informed, going against the norm risks being singled out or criticized”.
Stakeholders call for ongoing collaboration with the industry, prioritizing scientific and clinical evidence over promotional efforts. However, mutual distrust persists, exacerbated by insufficient regulation.
Patient 2: “Innovative drug manufacturers push to promote specific indications through civil society, which ultimately undermines its credibility. Clear boundaries must be established”.
Hospital-based Professional 2: “Caution is needed when educating patient groups because if oncologists struggle to understand these concepts, patients will find it even more challenging”.
Hospital-based Professional 4: “In procurement processes, physicians attempt to introduce certain criteria—sometimes subtle loopholes—that allow for differentiation in favor of the originator drug”.
Policymaker 9: “Industry interests may influence some patient organizations. Additionally, there is insufficient regulation regarding conflicts of interest—physicians are not subject to any control mechanisms”.
There is a perpetual concern regarding the presence of medications from Asian origins and/or those whose entry occurred prior to Norm N°170.
Hospital-based Professional 1: “During the era of bioequivalents, there were pivotal communication moments, such as when the Minister was photographed sitting next to the head of India’s regulatory drug agency, dressed in traditional attire. Those images were very powerful”.
Policymaker 2: “Physicians will not take the risk of prescribing biosimilars, particularly due to concerns that lower-quality alternatives, such as Indian-manufactured biosimilars, may enter the market”.
Policymaker 2: “It is important to learn from the experience with generics. They are necessary, but they must be equivalent. This is the only way to build trust. It is very unfair that the national laboratory has to compete with India. The good ones are paying for the bad ones. There is unfair competition between reference products and biosimilars”.
Hospital-based Professional 5: “I completely agree with using biosimilars, but only with good biosimilars”.
Facilitators were also explored, including general agreement on the acceptability of initiating biosimilars in naïve patients. Experts recommend securing strong evidence of effectiveness, especially in supportive therapies, to build trust and gradually transition to core therapies.
Hospital-based Professional 1: “For a biosimilar program to be attractive to hospitals, the logical approach is to target treatment-naïve patients, because switching patients from the originator drug is complex due to resistance to interchangeability. Many patients, for various reasons, require biosimilar granulocyte colony-stimulating factors, and since we have been using these molecules for years, they are already well-integrated into oncology care as supportive rather than core therapies. This provides an opportunity to gain experience and reduce concerns regarding biosimilars. In cases such as breast cancer, where drugs like trastuzumab are central to treatment, the initial adoption of biosimilars may be challenging. However, using biosimilars in supportive therapies is a more acceptable starting point—it follows the path of least resistance”.
Hospital-based Professional 1: “We are at a turning point where oncologists and hematologists, if given the option to use biosimilars, will accept them, simply because the State is not providing access. In many cases, patients wouldn’t have access to treatment if it weren’t for clinical trials. Clinical trials have become a de facto access route, reflecting how dire the situation has become”.
Interviewees raised concerns about the fragmentation of patient cohorts receiving different biosimilars for the same indication, leading to legal, operational, and administrative challenges. This complicates clinical management, especially in facilities with inadequate information systems to support data management needs.
Hospital-based Professional 3: “The procurement process is complex because I have patients receiving the reference biologic drug and biosimilars for the same cancer. I need to track how many patients are on each treatment, how many doses have been administered, the current stock levels, and what needs to be reordered. Additionally, when a new biosimilar from a different manufacturer arrives, I must be even more vigilant about potential adverse events”.
Hospital-based Professional 4: “Ideally, I would like to treat my patients with a single brand rather than the current situation where one month we have one brand and the next month another. Since there is often no continuity in the availability of the same medication, we may run out of the reference product and only have the biosimilar. We practice interchangeability, but we are not entirely comfortable with it. The brands keep changing”.
Hospital-based Professional 5: “We had four different patient groups receiving four different biologics—the reference product and three authorized biosimilars—all for the same cancer and indication. Every time a new biosimilar enters the market, we face the same challenge—creating an additional patient cohort to monitor”.
Purchasing
Interviewees report limited availability of evidence regarding cost savings and variability in the percentage of savings achieved with biosimilars.
Policymaker 5: “There is no structured analysis where someone evaluates and determines that, for example, switching to trastuzumab biosimilar could lead to greater savings”.
Policymaker 1: “The health technology assessment agency of the Ministry of Health does not receive costs, cost-effectiveness, or cost-minimization evidence of biosimilars. The submissions we receive come from large, innovative pharmaceutical companies. Manufacturers of biosimilars do not typically conduct cost-effectiveness studies”.
Policymaker 8: “Cost evidence for biosimilars is rare. Biosimilar companies do not invest in such studies. Occasionally, they may provide a simple comparison table showing the price of the innovator drug versus their biosimilar, stating that their cost is 20–30% lower. Sometimes, as insurers, we have to create these tables ourselves”.
There is consensus on the limited evidence of biosimilars’ budget impact. Stakeholders argue that companies have not convincingly demonstrated their value as quality and cost-effective options.
Policymaker 8: “Biosimilars should demonstrate they offer a better cost-effectiveness profile while maintaining the same quality. The budgetary impact of incorporating these alternatives should be shown, but that information is never calculated, and we don’t understand the full impact. People come to show you the price”.
Hospital-based Professional 2: “I honestly don’t know how much is saved. No one knows”.
Patient 2: “A 30% decrease sounds like smoke and mirrors. Aside from the industry selling biosimilars, no other entities have approached me with evidence of savings. They always throw out the magic number of 30% savings, but they’ve never provided the study”.
Patient 3: “I haven’t received any studies on the cost savings of biosimilars. What always raises concerns is the doubt about whether the savings are significant or if we’re only saving 15 bucks per person. For 15 bucks, we’ll stick with the originator”.
Incentives to promote the use of biosimilars in coverage schemes are unclear.
Policymaker 6: “The problem is that there are few incentives to generate savings”.
Hospital-based Professional 5: “In the case of the Ricarte Soto law, the high-cost drug system, there is no incentive to adopt biosimilars. From the hospital’s perspective, they don’t pay for it. If the regulation stated that there were no issues with substitution and the administrative problems at the centers were resolved, they would adopt them”.
Hospital-based Professional 2: “I don’t know who captures the savings (with biosimilars). As an oncologist, I am not clear on that. I have no idea if we capture any savings, and if so, I don’t know who takes them”.
Comparisons are made between biosimilar and reference molecule manufacturers in terms of value propositions, market access strategies, and team structures. Reference molecule companies are considered strategic partners, while biosimilar companies focus primarily on price-based discussions.
Hospital-based Professional 4: “The biosimilar industry doesn’t offer the same value proposition as innovative laboratories. Some of the originators even have nurses, follow-up programs … and biosimilars don’t have that. Their only play is being cheaper. Their whole strategy is based on price”.
Hospital-based Professional 2: “The marketing departments of those biosimilar companies are smaller too, which means less impact, and they focus heavily on pricing, always saying— I do the same but cheaper— instead of saying —we are the same”. They don’t do what the originator industry does, which floods you with information, connects you with the physician who led the study”.
Policymaker 4: “The originator laboratories warn us to be careful with biosimilars, about their adverse events, that they’re not entirely the same, that there are biosimilars sent to Europe and others sent here”.
Policymaker 5: “The innovators are in a much broader position than just working with the drug itself. They’re working on the patient journey. They offer many other things hospitals can benefit from, and it’s tough to lose them as a strategic partner”.
Patient 3: “There has been education toward patient group leaders by innovators to explain why “No” to biosimilars, why no automatic substitution, that there are no switch studies, and why they could pose a risk”.
Adherence
There is a persistent association in narratives linking biosimilars to poor quality and concerns about their effectiveness in oncological diseases. Additionally, fears of adverse events complicate patient adherence.
Patient 4: “Biosimilars could be used for treatments that are already nearly obsolete, but not for conditions like triple-negative breast cancer. When we talk about patients with cancer or rare and complex diseases, I don’t know how viable it is to use biosimilars. If I were asked today whether I would take a biosimilar, I would say absolutely not. At least not in cancer. In cancer, no. I feel that with biosimilars, there will be more adverse events compared to the originator drug”.
Hospital-based Professional 2: “For patients, switching to a biosimilar increases anxiety”.
Hospital-based professionals express concerns about a potential link between biosimilars and disease progression in oncology.
Hospital-based Professional 3: “A patient might think that if they later develop metastasis or fail to achieve a complete response, it could be due to switching from the originator drug to a biosimilar. We chose not to make the switch due to this susceptibility”.
Policymaker 1: “It is complex from a cultural standpoint. Patients associate quality with price—if it’s more expensive, it must be better”.
Recommendations for improving the value proposition for biosimilar adoption in the Chilean healthcare setting
The biosimilar adoption value proposition should articulate the following principles: Safe and properly regulated biosimilars in Chile enable timely access to clinically effective therapies. By reducing the budgetary impact of cancer care, biosimilars expand coverage and extend care to more patients. This approach supports fulfilling the social contract by promoting equity in treatment access and creating fiscal space for innovation by alleviating pressure on public healthcare budgets.
This analysis identifies recommendations for improving the value proposition of biosimilars based on gaps and actions. The gaps described reflect both direct observations from the interviewees and insights inferred by the authors. The proposed actions to address these gaps are derived from stakeholder narratives and supplemented by the authors’ recommendations.
Five critical dimensions were examined. In scientific evidence, interviewees noted the lack of international evidence presented in accessible and synthesized formats, the absence of national guidelines for switching, and the lack of a formal systematization of local switching experiences. In medical education, biosimilars were often associated with poor manufacturing quality, and a general deficiency in structured educational efforts was reported. Regarding economic evidence, there was limited clarity on the value proposition of biosimilars, low awareness of their potential budget impact when expressed in comparative figures, and insufficient incentives to encourage their uptake. A coherent engagement strategy was lacking in the domain of stakeholder engagement, and the biosimilar industry was perceived as having a weak presence in the national landscape. Finally, in public positioning, biosimilars suffered from low media visibility, a lack of collective awareness about their benefits, and ongoing concerns about their quality. These findings highlight the need for targeted, context-sensitive interventions in Chile to overcome structural and perceptual barriers to biosimilar adoption. For this purpose, we propose a five-dimensional roadmap as reported in Figure 2.
Discussion
As recommended in our work, access to biosimilars is a multi-pathway journey. The 2020 ASCO Recommendations on Biosimilar and Interchangeable Products in Oncology focus on key dimensions related to patients and clinicians, payers, pharmacy, government, and research [8]. Also, recommendations for Latin America suggest better education for interchangeability, collaboration among stakeholders, and education on their economic benefits [16].
Studies emphasize the crucial role of medical education, particularly regarding the evidence and data required for regulatory approval pathways [17], which was a common finding in our research. The widespread adoption of biosimilars will depend on the ongoing education of healthcare professionals and key stakeholders [17] to tackle negative attitudes and misinformation with deleterious effects [10, 18]. The bottom line of recommendations for increasing biosimilar´s adoption in Latin America acknowledges the need to strengthen regulatory guidelines in countries such as Colombia, Ecuador, Peru, Costa Rica, Panamá, Dominican Republic, El Salvador, Guatemala and Honduras [18]. However, despite countries such as Chile, Colombia, Ecuador, Guatemala, and Peru do count upon with regulations for regulatory approval of biosimilars [19], there is still lack of clear national policies to incentivize the adoption of biosimilars, beyond registry [18]. Nonetheless, the absence of strong or clear national recommendations does not prevent the private sector or hospitals from implementing pilots with the potential to improve biosimilars uptake. As reported in Brazil, the cooperative health company Unimed achieved costs reductions of 55.9% by adopting biosimilars, supported in a three-pilar plan grounded on medical education, specific protocols and profiling per disease, and specific acquisition principles to support strategic actions for pharmacovigilance and education [20].
International studies emphasize the need to establish national recommendations for switching biological medicines to facilitate the adoption of biosimilars [21]. Our findings confirm the negative effects on physicians derived from the lack of local guidelines for interchangeability. The lack of standardization for switching and lack of support for physicians has also been reported in the case of Brazil, Colombia [18] and Argentina [22]. Some physicians have also raised apprehensions about their autonomy [19] based on concerns about pharmacy or automatic substitutions [6]. These events have also been stated in the Chilean setting.
Edgar Babette et al. identified three primary strategies to overcome access barriers to biosimilars: educational programmes for prescribers focusing on evidence from studies involving switching to biosimilars, educational programmes emphasizing real-world evidence from post-marketing studies, and reduced cost-sharing for patients using biosimilars [9], as reported in the Brazilian experience. Additionally, their work highlights reimbursement-based strategies, including incentivizing providers by adjusting fee schedules for biosimilars, promoting biosimilar prescribing for treatment-naïve patients through quotas and formulary tools, and educational programmes for prescribers addressing streamlined billing, coding, and reimbursement processes for biosimilars [9]. Evidence shows that patients [7] and physicians are less reluctant to initiate biosimilars in naïve cases over a switch [23], a point further underscored by interviews conducted in Chile, which identified these as potential facilitators. The Nordic experience with biologicals-naïve patients diagnosed with rheumatic diseases supports similar retention rates in patients treated with originators versus biosimilars for infliximab and etanercept, indicating comparable effectiveness in clinical practice. Likewise, survival probability curves were highly similar for the originator and its biosimilar [24].
An analysis that assessed the price difference between reference products and biosimilars across a diverse therapeutic spectrum estimated that, in Brazil, the median price difference reached up to –36.3%, while in Argentina it was –18.6% [25]. However, in human epidermal growth factor receptor 2 (HER2)-positive patients, the premise of a lower-priced biosimilar is insufficient to claim a cost-efficient profile of biosimilars as the administration changes from subcutaneous to intravenous, leading to the consumption of additional direct and indirect cost drivers. This puts further pressure on adequate prices to offset the extra costs. However, a cost-effectiveness analysis comparing trastuzumab biosimilars with the reference trastuzumab in France demonstrated cost savings in two tested scenarios, ranging from €12 to €51 per patient per year [26]. Estimations for five European countries suggest that biosimilars in breast cancer could result in net savings ranging from €19 million to €172 million, potentially expanding access for 622 to 3,688 additional patients [27]. A similar analysis for 28 European countries estimated savings of €39.74 million in early breast cancer and €14.96 million in metastatic breast cancer [28]. The only locally published budget impact model assessed the introduction of biosimilar intravenous rituximab for patients with follicular lymphoma and diffuse large B-cell non-Hodgkin lymphoma from the perspective of the Chilean healthcare system. The analysis demonstrated net cost savings of US$208,553 in 2023, equivalent to US$6,728 per patient. These savings could potentially expand access to 49 additional patients [29].
Despite the various benefits of cost-savings and health equity improvement, our findings and international experiences with benefit-sharing programmes highlight persistent concerns regarding the lack of transparency in how the savings generated by biosimilars are distributed and subsequently allocated. These gaps reflect broader challenges in communicating a clear and compelling value proposition [30].
A systematic review supports our findings, suggesting that improvements in financial capacity and cost savings are positively highlighted by decision-makers. Nonetheless, this is not significant for patients [7]. In the Canadian experience, patients were educated about the nature of biosimilars, learned about the lower costs for the government, and were referred to support groups within the health system and family networks. Nevertheless, before the switch, patients expressed concerns about differences in efficacy and safety, and frustration with the decision [31].
It is essential to align efforts to improve access not in isolation but through synergy. Rieger et al. supports this idea [7] based on Petit J et al., who argue that enablers are interdependent. While centralized substitution policies may be helpful, their effectiveness depends on how they are implemented within the physician–patient relationship [32]. For example, patients have identified medical interviews and the positive framing of the switch or use in naïve patients as key enablers [7]. This approach has become the ground for our proposals for the Chilean healthcare setting based on the combination of five dimensions towards a better value proposition to advocate for the value of biosimilars.
This study offers valuable insights into biosimilar adoption barriers in Chilean oncology; however, limitations must be noted. The qualitative approach precludes causal inference and limits the ability to assess the relative importance of each barrier. Snowball sampling may have introduced selection bias by over-representing specific profiles. Additionally, participation bias is likely, as interviewees were those willing to engage—typically individuals more open or favourable toward biosimilars—potentially underrepresenting more critical views. The value chain framework was applied descriptively, without fully examining interactions between strategic activities. The applicability of findings to other health systems is also limited, as the analysis is deeply contextualized within the Chilean regulatory and financing landscape.
Conclusion
This work has identified the main barriers perceived by key stakeholders in Chile that hinder improved access to biosimilars in oncology. Addressing these challenges requires coordinated, multisectoral actions rather than isolated efforts. Our findings underscore the importance of synergy across the healthcare system to improve biosimilar access. This insight forms the basis of our proposals for the Chilean context, which are structured around five interrelated dimensions to strengthen biosimilars’ value proposition. These dimensions are intended to serve as a roadmap to advocate more effectively for their role in expanding equitable access, generating fiscal sustainability, and creating space for innovation.
Acknowledgement
Part of these findings were presented in the module Management and Economic Evaluation of the Chilean Society of Oncological Pharmacy National Symposium, in August 2024.
Funding sources
Abbott Chile provided funding for the publication; the researchers maintained complete independence from the design to the interpretation of the results. Abbott Chile was not involved in data collection, analysis, or manuscript preparation.
Competing interests: The authors declare past health economics studies conducted within the last 36 months for pharmaceutical and medical device companies in areas unrelated to the field of biosimilars. Further details are provided in the conflict-of-interest disclosure form.
Provenance and peer review: Not commissioned; externally peer reviewed.
Authors
Associate Professor Daniela Maria Paredes-Fernández, RM, MPH
Associate Professor Rony Christian Lenz-Alcayaga, MA
Universidad Andrés Bello – Public Health Institute, #700 Fernandez Concha Street 7591538, Santiago, Chile
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Author for correspondence: Associate Professor Rony Christian Lenz-Alcayaga, MA, Public Health Institute, Universidad Andrés Bello, #700 Fernandez Concha Street 7591538, Santiago, Chile |
Disclosure of Conflict of Interest Statement is available upon request.
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