Budget impact analysis of implementation of biosimilars in a private health insurance company of large size in Southern Brazil
Published on 24 March 2026
Generics and Biosimilars Initiative Journal (GaBI Journal). 2026;15(1).
Study objectives: To evaluate the budget impact of implementing a physician-led biosimilar switching programme within a large private health insurance company in Southern Brazil. |
Introduction
Immune-mediated inflammatory diseases (IMIDs) are conditions in which the immune system attacks the body, leading to chronic inflammation and tissue damage. This category includes autoimmune diseases such as rheumatoid arthritis, lupus, inflammatory bowel disease (IBD), and multiple sclerosis, as well as autoinflammatory conditions. It is estimated that one in 10 people worldwide suffer from an autoimmune condition [1]. The cost of treating these conditions places a considerable burden on healthcare budgets. Many IMIDs can be effectively managed with biological medicines. While originator/reference products are often expensive, the approval and global availability of more affordable biosimilar options have expanded treatment access. Additionally, biosimilars for oncology indications are increasingly being adopted as cost-effective cancer treatment options.
Brazil has a public-private healthcare system, with many individuals opting for private health insurance. According to the Agência Nacional de Saúde Suplementar (ANS), approximately 53.3 million Brazilians—about 25% of the population—are covered by private health insurance plans [ANS/IDEC] [2]. Private insurers in Brazil now offer treatment options with more affordable biosimilar products, and widespread biosimilar adoption has the potential for substantial impact on national healthcare expenditure.
In 2010, ANVISA (Agência Nacional de Vigilância Sanitária), Brazil’s National Health Surveillance Agency, introduced regulations (RDC 55/2010) to establish a licensing pathway for follow-on biological products (biosimilars) using a comparability exercise. These regulations are based on international guidelines, including the World Health Organization (WHO) Similar Biological Product Guidelines [3].
In some regions, such as the United States, biosimilars can receive an ‘interchangeability’ designation, allowing for pharmacy-level substitution without physician approval [4]. In Brazil, no specific interchangeability guidelines currently exist. Any switching between an originator biological and a biosimilar is guided by recommendations from relevant medical societies, e.g. those for gastroenterology, rheumatology [5]. These societies define the ideal patient profile and conditions for switching [6, 7]. Despite this, the potential benefits of introducing a formal interchangeability designation in Latin America have been discussed [8].
While the economic benefits of switching to biosimilars are well-documented in North America and Europe [9], real-world evidence on the budget impact of managed switching programmes within the specific context of the Brazilian private insurance market remains limited. Additionally, biosimilar uptake can face challenges, primarily related to prescriber and patient education and trust.
Study objective
To evaluate the impact on pharmaceutical expenditure when a managed switching program, from originators to biosimilars, is implemented in a large private health insurance provider in Brazil. With approximately 53 million Brazilians covered by private health plans, widespread biosimilar adoption could have a substantial impact on national healthcare spending [2].
Method
Study design and data source
This was a retrospective, observational, single-centre study conducted from a private payer perspective. We utilized real-world data from the insurer’s business intelligence system, which contains comprehensive records on patient utilization and associated costs. A budget impact model was developed to evaluate the savings achieved by the insurer following the implementation of a biosimilar switching programme over a 24-month period (November 2022 to October 2024).
The analysis focused on medications reimbursed for indications approved by the Brazilian Regulatory Agency for Private Health Insurance and Plans (Agência Nacional de Saúde Suplementar, ANS). The model tracked the number of patients treated monthly over the 24-month period, which was further divided into six ‘quadrimesters’ (four-month periods) for trend analysis.
Medications analysed
The study included biological medications used for treating autoimmune diseases and oncology.
The autoimmune medications are monoclonal antibodies that inhibit tumour necrosis factor alpha (TNF-α), indicated for conditions such as ankylosing spondylitis, Crohn’s disease, psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis:
- Adalimumab [10]
- Etanercept [11]
- Infliximab [12]
The oncology medications, also monoclonal antibodies, included:
Bevacizumab – inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (VEGF-A). Bevacizumab can therefore slow the growth of new blood vessels in tumours and is used to treat various cancers, including colorectal, lung, breast, glioblastoma, kidney and ovarian [13].
Rituximab – acts against the protein CD20, which is primarily found on the surface of immune system B cells. Rituximab destroys B cells and is therefore used to treat diseases that are characterized by excessive number of B cells, overactive B cells or dysfunctional B cells. This includes many lymphomas, leukaemias, transplant rejection and autoimmune disorders [14].
Trastuzumab – binds to and inactivates the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast cancers, HER2 is overexpressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat HER2 positive (HER2+) breast cancers [15].
In the first year of study, only biological-naïve patients were prescribed biosimilars. In the second year, a managed switching programme was initiated, where existing patients on originator biologicals were transitioned to a biosimilar, always with the agreement of their prescribing physician. During the period of the study, 1,131 patients received a biosimilar for the first time.
A two-year cost comparison was performed between biosimilars and their corresponding reference biologicals for all six molecules: infliximab, adalimumab, etanercept, rituximab, trastuzumab, and bevacizumab.
Reimbursement values, as determined by the insurer, were extracted from the payer’s claims database. These values were non-static throughout the study. All costs were converted from Brazilian Real (R$) to US dollars (US$) using the period-specific exchange rate of R$6.00:US$1.00.
Results
The analysis cohort included all patients on biological therapy at the index date (November 2022) who were subsequently treated with one of the selected biosimilars. These patients were followed through October 2024.
Conversion rates varied by medical specialties. The highest rates were observed in oncology, reaching 100% for bevacizumab, 98% for trastuzumab, and 100% for rituximab by the end of the period. The analysis comprised 1,131 unique patients over the 24-month period, which is lower than the total patient-months of treatment as presented in Table 1. This reflects the dynamic nature of the cohort, where patients initiated and discontinued therapy throughout the study. The total cost savings associated with biosimilar use was US$1,488,290.73.
Cost savings and treatment volume varied by molecule, as detailed in Table 1.
Table 1 presents the total cost savings and accumulated patient-months of treatment for each biosimilar molecule over the 24-month study period. Across all six molecules, biosimilar use generated total savings of US$1,488,290, for 1,131 unique patients, which is lower than the accumulated patient-months. This is expected due to patient turnover—a natural phenomenon resulting from deaths, changes in insurance, treatment suspension, or switching to a molecule without a biosimilar option. For clarity, each patient who received a biosimilar was counted only once per month in the analysis. In Brazil, annual patient turnover in insurance companies can exceed 30%.
The magnitude of savings varied considerably by molecule and was closely related to treatment volume. Adalimumab, the most widely used biosimilar with 745 patient-months, contributed the largest savings at US$897,822—accounting for approximately 60% of total savings. Infliximab followed, with 242 patient-months and savings of US$318,796. Among oncology biosimilars, trastuzumab (239 patient-months) generated US$198,085 in savings, while bevacizumab (121 patient-months) contributed US$37,080.
Molecules with lower patient volume, such as rituximab (2 patient-months) and etanercept (3 patient-months), produced more modest savings of US$33,100 and US$3,404, respectively. Despite their limited utilization, their inclusion reflects the insurer’s commitment to biosimilar adoption across all therapeutic areas where biosimilars are available.
Overall, Table 1 demonstrates that cost savings are driven primarily by high-volume molecules, particularly adalimumab and infliximab, while oncology biosimilars also made meaningful contributions despite lower patient volumes.
Over the full 24-month period, biosimilars represented 39% of total biological patient-months at the start of the study (November 2022, with 365 patient-months) and 86% by the end (October 2024, with 436 patient-months). In absolute terms, biosimilar patient-months increased from 141 to 375 over the same period. This substantial shift toward biosimilar use demonstrates expanded patient access to biological therapies.
Figure 1 illustrates the trend in biosimilar adoption over the 24-month study period, divided into six quadrimesters (four-month periods). In the first year (quadrimesters 1–3), when only naïve patients received biosimilars, the biosimilar share of total patient-months remained relatively stable, increasing modestly from approximately 39% to 42%. During this phase, originator patient-months exceeded biosimilar patient-months: across quadrimesters 1 to 3, originators accounted for 674 patient-months compared to 453 for biosimilars, representing approximately 40% of total patient-months.
In the second year (quadrimesters 4–6), the implementation of a physician-led switching programme for existing patients led to a marked increase in biosimilar uptake. The biosimilar share of patient-months rose from 58% in quadrimester 4 to 86% by quadrimester 6. Across quadrimesters 4 to 6, this trend reversed dramatically: biosimilars accounted for 919 patient-months versus 330 for originators—nearly three times more patient- months of treatment with biosimilars.
By the sixth quadrimester, market competition had led to price convergence, equalizing the cost of originator and biosimilar versions of adalimumab and infl iximab. This downward pres- sure on originator prices resulted in a lower overall market cost for these molecules.
Notably, due to the high volume of adalimumab use and the sharp reduction in its originator price, the average cost per treat- ment for biosimilars was temporarily higher than for originators during this convergence period, see Figure 2. Despite this, the overall expenditure in the last quadrimester dropped significantly, reflecting both the reduced cost of originators and the continued increase in the number of patients accessing biosimilars, see Figure 2.
Figure 2 presents total expenditure (bars) and average cost per patient-month (lines) for both biosimilars and originators over the six quadrimesters. In periods 1 to 3, total expendi- ture on originators (purple bars) substantially exceeded that on biosimilars (green bars), driven by higher originator utilization and higher average cost per patient-month (red line vs blue line). For example, in quadrimester 1 (November 2022), originator expenditure was US$481,441 compared to US$175,918 for biosimilars, resulting in total expenditure of US$657,359. The average cost per patient-month in this period was US$2,149 for originators versus US$1,248 for biosimilars, with a total of 365 patient-months.
As biosimilar uptake increased from quadrimester 2, total expenditure on biosimilars rose, refl ecting the growing number of patients receiving these biologicals. By quadrimester 5, total biosimilar expenditure (US$403,072) exceeded that of originators (US$211,120). Throughout most of the study, the average cost per patient-month for biosimilars remained consistently lower than for originators—approximately 40% lower—as shown by the blue line.
In quadrimester 6 (October 2024), price competition led to convergence of average costs, with the originator average cost per patient-month (red line) decreasing to US$791—below the biosimilar average of US$1,174. Notably, despite this cost convergence and the highest patient volume of any period (436 patient-months), total expenditure in quadrimester 6 (US$488,645) was the lowest of the study. This was driven by a dramatic shift in spending: originators accounted for just US$48,264 (approximately 10%), while biosimilars accounted for US$440,380 (approximately 90%)—a 26% reduction in total quadrimester expenditure compared to period 1, despite a 19% increase in patient-months. This demonstrates that biosimilar competition reduced overall biological spending while simultaneously expanding patient access to treatment.
While aggregate data demonstrate significant overall savings and increased biosimilar adoption, utilization patterns varied considerably across individual molecules. Table 2 presents biosimilar utilization rates for each molecule, comparing quadrimester 1 (Q1) to quadrimester 6 (Q6).
Table 2 presents biosimilar utilization rates for each molecule, comparing quadrimester 1 (Q1) to quadrimester 6 (Q6). Across all molecules, biosimilar adoption increased, though the magnitude varied by therapeutic class, baseline utilization, and patient volume.
Among oncology treatments, bevacizumab (121 patient-months) and rituximab (2 patient-months) both reached 100% biosimilar utilization by Q6, while trastuzumab (239 patient-months) increased from 77% to 98%. These high conversion rates demonstrate strong physician acceptance of oncology biosimilars.
For autoimmune indications, adalimumab—the most frequently used molecule in the study with 745 patient-months—rose from 37% to 66% biosimilar share. Infliximab (242 patient-months) increased from 43% to 86%, aligning with the overall study average. Etanercept had limited uptake, rising from 0% to 21% with only 3 patient-months, reflecting its minor role within the insurer’s portfolio.
Overall, four of six biosimilars exceeded 86% utilization by Q6 (infliximab, rituximab, bevacizumab, and trastuzumab), while adalimumab and etanercept demonstrated more modest gains. Despite these differences, all molecules contributed to the aggregate 86% biosimilar share achieved by study end, reflecting broad-based increases in biosimilar adoption over the 24-month period.
Discussion
The results demonstrate that in the first year, when only näive patients were prescribed biosimilars (c. 40%), the impact on overall expenditure was limited due to the continued high cost of originator use for the majority. However, in the second year, the implementation of a physician-led switching programme for existing patients led to a marked increase in biosimilar uptake and a corresponding reduction in overall biological expenditure. This trend underscores the critical role of physician engagement in successful biosimilar adoption.
Furthermore, the price competition stimulated by biosimilar entry culminated in the sixth quadrimester, where originator prices for adalimumab were negotiated downward to match biosimilar levels. This competition led to the lowest overall expenditure on biologicals during the study period, even as the number of treated patients reached its peak.
These findings align with global evidence showing that policies promoting biosimilar switching can significantly reduce healthcare expenditure [16]. They highlight the substantial potential for further cost savings in Brazil by increasing biosimilar uptake through physician-led initiatives. Policymakers should consider strategies to accelerate biosimilar adoption, such as developing a clear interchangeability framework. However, as seen in other jurisdictions, the successful implementation of such policies must be accompanied by comprehensive education for healthcare providers, patients, and other stakeholders to address knowledge gaps and mitigate negative perceptions.
This study is limited by its 24-month timeframe. While it captures the initial impact of switching and market competition, a longer-term follow-up would be beneficial to understand more about how competition affects the uptake of biosimilars and sustains lower expenditure over time in Brazil. For instance, it would be valuable to explore whether the reduced originator prices are maintained and whether patients switch back to originators following price convergence.
Conclusions
This study demonstrates that over a 24-month period, biosimilar uptake in a large Brazilian private health insurer expanded significantly following the implementation of a physician-led switching programme. This uptake contributed to a reduction in the average cost of treatment, not only by providing lower-cost alternatives but also by stimulating market competition that lowered originator prices.
Looking forward, policies that encourage switching, such as establishing an ‘interchangeability’ designation for biosimilars, could have a profound impact on their adoption. As this study shows, increased competition can effectively reduce prices for both biosimilars and originators, lowering overall payer expenditure on biologicals. To realize these benefits, regulatory, economic, and technical challenges must be addressed, alongside targeted educational initiatives for all stakeholders.
Funding sources
This study was funded by Organon Brazil.
Declarations
This study was presented as a poster (ISPOR 2025 Code: EE297) at the ISPOR 2025 Annual International Conference, Montreal, Canada.
Competing interests: The authors declare no conflicts of interest.
Provenance and peer review: Not commissioned; externally peer reviewed.
Authors
Rafael Gama1, MD, MBA, ORCID 0009-0007-5674-135x
Adjunct Professor Valderilio Feijó Azevedo2, MD, PhD, MSc
Paula Heberle3, MBA
Sergio Mauricio Menoncin3, MSc
Daniela Toigo3, MBA
Fabiana Aguiar3, PG
Josymar Nascimento Júnior3, MD
Ana Carolina Maciel3, PG
Ricardo Luiz Pereira Bueno4, BA, MHA, PhD
1Health Economics, Medical Intelligence Management Specialist in Healthcare, 43, Praxedes Silva Avelleda St, 82410-420 Curitiba, Brazil
2Clinica Médica, Universidade Federal Paraná, 24 Rua Alvaro Alvin, Casa 18 Seminário, PR-80740-260 Curitiba, Brazil
3Unimed Blumenau, R Alm Barroso, Blumenau, Santa Catarina, Brazil
4Graduate Program on Corporate Governance, Centro Universitário das Faculdades Metropolitanas Unidas, Rua Afonso Braz, 889 – Indianópolis, CEP 04.511-011 São Paulo, Brazil
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Author for correspondence: Rafael Baptista Gama, MD, MBA, Medical Intelligence Management Specialist in Healthcare, 43, Praxedes Silva Avelleda St, 82410-420 Curitiba, Brazil |
Disclosure of Conflict of Interest Statement is available upon request.
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