Slow Biosimilar Uptake in Latin America Signals Missed Opportunities for Patient Access, Cost Savings

Despite the recognized potential of biosimilars to expand patient access to critical biologic medicines and significantly reduce health care costs, their uptake in Latin American (LatAm) countries has remained notably slow.¹ A recent manuscript, drawing on a comprehensive analysis involving key opinion leaders and industry representatives across Latin America and Europe, shed light on the multifaceted barriers hindering biosimilar adoption and proposed strategic initiatives to accelerate their use.²

Biosimilars promise cost savings and improved patient access in Latin America, yet face significant regulatory and educational barriers hindering their uptake. | Image credit: Olsek - stock.adobe.com

This study, published in Expert Opinion on Biological Therapy, underscored the urgent need for harmonized regulatory processes, robust education, and coordinated regional efforts to unlock the full benefits of biosimilars for patients and health care systems in the region.

“The impact of high-cost biologics is felt greatly in the LatAm region, where most of the population depends on underfunded public health systems. Moreover, there are considerable differences in the epidemiology and burden of cancer among countries in this region that further impact on patient outcomes…. The development and implementation of a standardized and streamlined regulatory process for biosimilars across the LatAm region, including translation into daily practice in a timely manner, is crucial,” wrote the authors.

Health care expenditures in LatAm countries have been on a sharp upward trajectory, fueled by demographic shifts such as population growth and aging, alongside the increasing prevalence of chronic diseases like cancer. Biologic medicines, although vital, represent a disproportionately high share of drug budgets, creating significant access barriers for patients. Biosimilars offer a powerful solution by fostering price competition and enhancing affordability.

However, despite their proven benefits in regions like Europe and the US, their integration into LatAm health care systems has been sluggish, prompting this investigation into the underlying causes and potential remedies. According to a 2022 study, the LatAm biosimilar market had the potential to grow at a 33% rate annually to reach $3.9 billion by 2025.³

To understand the complexities of biosimilar uptake in Latin America, researchers convened an online forum of 6 key opinion leaders from Brazil, Chile, Mexico, and the UK, encompassing expertise in pharmacology, hematology, oncology, and health economics.¹ Two industry representatives from Latin America and Europe also participated, moderating discussions and providing crucial context. The group offered perspectives on the barriers impacting biosimilar acceptance in Latin America, drawing comparisons to European experiences.

Complementing these expert discussions, industry representatives from 12 LatAm countries completed a survey detailing their national biosimilar policies. The insights gathered from these discussions and survey results ultimately led to the identification of 6 key themes affecting biosimilar acceptance, which formed the core of the expert opinion.

Main Findings Highlight Critical Barriers

The analysis revealed a fragmented and inconsistent landscape for biosimilars across Latin America. Lack of harmonized regulatory processes was a significant challenge identified. Unlike the more uniform approach seen in Europe, LatAm countries often have unique and sometimes nonstandardized regulatory pathways, leading to delays in approval or, in some cases, the approval of "intended copy biologics" (ICBs) that do not meet rigorous international biosimilarity standards. For instance, the rituximab ICB Kikuzubam in Mexico was withdrawn due to higher-than-expected serious adverse effects, undermining trust in biosimilars.

Beyond regulatory hurdles, the study highlighted a scarcity of policies to actively incentivize biosimilar use. While some public health tenders in Chile favored biosimilars, a widespread lack of national policies and incentives for prescribers, particularly in the private sector, limited uptake.

This contrasts sharply with Europe, where initiatives like Ireland's "best-value biologic" program, offering enhanced prescriber payments, dramatically increased biosimilar market share and generated estimated cost savings of €22.7 million. Furthermore, confusion surrounding terminology like interchangeability and substitution, coupled with a lack of specific naming policies for biosimilars, contributed to misinformation among health care professionals (HCPs) and patients. This absence of clear national guidelines often left clinicians and patients to make individual decisions about switching.

Implications for the Biosimilar Industry and US Health Care

For the biosimilar industry, the study underscored the immense, yet largely untapped, market potential in Latin America, estimated to reach $3.9 billion by 2025. However, realizing this potential demands a proactive approach to advocating for policy reforms and investing in comprehensive stakeholder education.

For US health care, the challenges in the LatAm region serve as a reminder of the foundational importance of clear, harmonized regulatory pathways and robust educational efforts in fostering biosimilar trust and uptake. The FDA's recent clarification on biosimilar interchangeability, affirming confidence in all approved biosimilars, directly addresses some of the informational barriers identified in Latin America, demonstrating how regulatory clarity can empower prescribers.

Ultimately, the study reinforced that although biosimilars offer a powerful tool for health care sustainability, their full benefit can only be realized through concerted efforts that address regulatory consistency, stakeholder education, and strategic incentive programs that prioritize both affordability and patient confidence.

The authors concluded, “We can envision a future scenario for the position of biosimilars in [Latin America] based on what is currently taking place in Europe…. It is crucial to continue discussing and considering these future developments throughout [Latin America], especially as an increasing number of biologic reference drugs lose their patents and become targets for biosimilar development.”

References

1. Feijó Azevedo V, Mysler E, Aceituno Álvarez A, et al. Recommendations for the regulation of biosimilars and their implementation in Latin America. GaBI J. 2014;3(3):143-148. doi:10.5639/gabij.2014.0303.032

2. Schaffel R, Cornes P, Espinoza MA, et al. The potential role of biosimilars in healthcare sustainability in Latin America. Expert Opin Biol Ther. 2025;25(6):633-647. doi:10.1080/14712598.2025.2507173

3. Teran E, Gomez H, Hannois D, et al. Streamlining breast cancer and colorectal cancer biosimilar regulations to improve treatment access in Latin America: an expert panel perspective. Lancet Oncol. 2022;23(7):e348–e358. doi:10.1016/S1470-2045(22)00121-8