Introduction
The revolution of biological medicines—innovative therapies derived from living organisms—has transformed conditions once considered incurable or highly disabling, from cancer and rheumatoid arthritis to migraine, psoriasis, inflammatory bowel disease, and other autoimmune disorders, significantly improving life expectancy and quality of life for thousands of patients.
However, this success comes with a major challenge: biologics are typically high-cost therapies (ranging from USD 10,000 to USD 50,000 per patient per year) and can account for more than 40% of total pharmaceutical spending in several countries across the region. This financial burden places intense pressure on the sustainability of health systems, in a context marked by steadily growing demand for innovative therapies and persistently high health-care inflation in Latin America, which remains in double digits and exceeds 11% annually.
In this scenario, biosimilar medicines—biotechnological products that are highly similar in quality, safety, and efficacy to an innovative biological product whose exclusivity period has expired—emerge not only as additional therapeutic options, but as essential tools to optimize health-care resource allocation and ensure sustainability and equity in access to care. By fostering competition and significantly reducing treatment costs, biosimilars improve the affordability of biologic therapies, expand patient access to life‑saving treatments, and relieve financial pressure on health systems.
Moreover, when the savings generated through the use of biosimilars are reinvested in innovative health technologies and new treatments, they create a virtuous cycle, in which efficiency gains finance the next wave of medical innovation.
Low biosimilar penetration in the region
It has been 20 years since Europe approved the first biosimilar, and today more than 80 biosimilar products have been authorized globally, supported by robust evidence of safety and efficacy.
In high-income countries—particularly in Europe—biosimilars have already reached market shares above 70%, and even close to 90% in Scandinavian countries, generating substantial savings and enabling more patients to be treated in high‑cost therapeutic areas.
In Latin America, by contrast, adoption has been slow and uneven: in many countries, biosimilars still account for less than 30% of market share.
Even within specific public frameworks, penetration remains minimal. For example, in Chile’s high‑cost coverage system (Ley Ricarte Soto), biosimilars represent only around 7% of market value, compared with 93% captured by originator products. Similarly, Colombia and Peru report marginal biosimilar adoption, with public spending on these medicines remaining almost imperceptible over the past decade.
Paradoxically, the Latin American countries leading in biosimilar approvals—Brazil (65) and Mexico (54) as of 2025—are not immune to low effective uptake in clinical practice. It is worth noting, however, that Brazil has made tangible progress, particularly in the use of biosimilars for cancer treatment, while in Mexico adoption has been far more limited and comparable results have yet to materialize.
This low penetration is not epidemiologically neutral. It has a direct health impact that makes it a documented equity failure.
According to the Global Burden of Disease Study 2021 (GBD 2021), Andean Latin America records the highest age‑standardized incidence of rheumatoid arthritis worldwide, while Southern Latin America shows one of the sharpest increases in disease burden over the past three decades. In inflammatory bowel disease (IBD), the pattern is similar: countries with a medium sociodemographic index (SDI)—where most Latin American countries fall—exhibit systematically higher mortality rates and disability‑adjusted life years (DALYs) than high‑SDI countries, partly as a direct consequence of more limited access to biologics and biosimilars.
In other words: the region that needs these therapies the most is the one that uses them the least.
Multifactorial causes of the gap
Latin America’s lag in biosimilar adoption is not due to a lack of scientific evidence—the safety and efficacy of these products are solidly supported internationally—but rather to structural and institutional barriers that have hindered their use. Key factors include:
Regulatory frameworks
Despite recent efforts to harmonize regional guidelines with the WHO’s 2022 international recommendations—Brazil, for example, updated its biosimilar evaluation standards in 2024 to align them with European and U.S. frameworks, and Chile is currently in the process—clear policies on interchangeability and substitution are still lacking in many countries. While Europe explicitly states that all approved biosimilars are interchangeable, caution continues to prevail across much of Latin America. These regulatory delays and inconsistencies have constrained post‑patent competition, although recent trends point to gradual improvement in several markets.
Knowledge and trust among health professionals and patients
Information gaps and persistent myths surrounding biosimilars limit acceptance. Medical specialties with less prior experience using biosimilars tend to show greater caution, driven by uncertainty regarding efficacy or safety. Among patients, the so‑called nocebo effect also persists: the perception of receiving a lower‑cost medicine may induce perceived adverse effects or reduced effectiveness, undermining confidence.
Scientific evidence clearly refutes these concerns—numerous European studies demonstrate that switching from an originator biologic to its biosimilar does not compromise safety or clinical outcomes—but without strong public education campaigns in the region, many physicians and patients remain insufficiently informed. Expanding education for clinicians (through clinical guidelines and continuing medical education) and for patients (via accessible public information) is essential to dispel myths and reinforce trust in high‑quality biosimilar medicines.
Economic incentives and reinvestment of savings
Another major barrier is the lack of aligned incentives to encourage biosimilar prescribing and use. Few Latin American countries have formal gain‑sharing mechanisms. In the United Kingdom, for example, a portion of the savings generated through biosimilar use is reinvested in the same clinical department to fund staff or equipment, directly rewarding cost‑effective therapeutic choices.
In Latin America, the absence of such incentives means that many clinicians and hospitals perceive switching to a biosimilar as an administrative burden with no direct benefit. Furthermore, most health systems in the region lack transparent policies to reinvest biosimilar‑driven savings into new technologies. As a result, the virtuous cycle remains incomplete: freed‑up resources are absorbed into general budgets rather than visibly reinvested in improved care. This fuels inertia—“why change?”—and, more concerningly, sustained low uptake discourages manufacturers from launching biosimilars in the region, weakening competition and perpetuating dependence on high‑cost therapies.
Public procurement design and sustainable competition
Finally, procurement and reimbursement policies play a decisive role. Many tenders in Latin America are awarded solely to the lowest bidder under a single‑winner model. While this may reduce costs initially, it can disincentivize long‑term participation by multiple suppliers and increase the risk of future supply shortages. Experts increasingly advocate for more sophisticated procurement strategies—such as multi‑winner tenders or market‑share allocations—that preserve competitive pressure while ensuring supply security.
International lessons and success stories
While each country must define its own strategy, learning from international experience is essential.
In Canada, several provinces have implemented mandatory switching programs from originator biologics to biosimilars within public health systems, rapidly achieving market shares above 70% in anti‑inflammatory and oncology drugs. In Denmark, Norway, and other Nordic countries, aggressive substitution strategies have pushed biosimilar uptake above 90% for key biologics—without compromising safety or effectiveness—supported by strong real‑world evidence and strict pharmacovigilance.
In the United Kingdom, the NHS introduced the Best Value Biological Medicines policy, positioning biosimilars as the preferred option through national prescribing targets, competitive procurement, and structured reinvestment of savings at the institutional level.
Conclusion
Latin America stands at a crossroads. The persistently low adoption of biosimilars reflects a system that has too often prioritized inertia and fragmentation over efficiency and equity. This is not about technical incapacity or lack of evidence: the region already has regulatory expertise and multiple local and international examples to draw upon.
What is urgently required is political will and coordinated action among all health‑sector stakeholders—regulators, payers, providers, health professionals, and patients—to move decisively from diagnosis to implementation.
Biosimilars are not merely cost‑containment tools; they are a cornerstone for sustainable, equitable health systems capable of meeting the growing burden of chronic and complex diseases in Latin America.
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