Boosting Health Care Sustainability: The Role of Biosimilars in Latin America

Biosimilars can significantly improve access to biologic treatments and health care sustainability in Latin America (LA), but addressing misconceptions, regulatory gaps, and weak pharmacovigilance is essential for their broader adoption, according to a new study.¹

The study, published in Advances in Therapy, analyzed responses from a panel of experts convened by the Americas Health Foundation (AHF) identified key steps to address these issues. In resource-limited health care settings like LA, where challenges and health disparities are significant, biosimilars could offer great benefits, but adoption has been slow.² This lag is largely due to limited awareness and acceptance among health care stakeholders, inconsistent regulatory frameworks across the region, and insufficient pharmacovigilance systems.

The AHF convened a multidisciplinary panel of 6 biosimilar and interchangeability experts from Brazil, Chile, Colombia, Ecuador, and Mexico to develop guidelines for biosimilar interchangeability in LA. Using PubMed, MEDLINE, and EMBASE, the AHF conducted a comprehensive literature review of articles published between 2018 and 2023 in English, Portuguese, and Spanish, prioritizing research from LA.

Panel members were assigned specific questions based on this research, provided written responses informed by the literature and their expertise, and collaboratively refined their recommendations during a 2-day virtual meeting. The resulting guidelines reflect consensus-driven evidence and expert opinions, without involving new studies on human or animal subjects.

Regional Overview

The first biosimilar regulatory pathway was established in Europe in 2005, followed by the US in 2010, with biosimilar guidelines also implemented in LA and other regions. Although Europe has achieved notable biosimilar uptake, accounting for 10% of biologics by 2021, adoption in the US and LA has been slower.

Latin America, an emerging market with diverse health care systems and regulatory environments, has made significant progress by aligning biosimilar regulations with World Health Organization (WHO) and European Medicines Agency (EMA) guidelines. However, barriers such as limited awareness, inconsistent adherence to regulations, and weaknesses in pharmacovigilance continue to impede biosimilar uptake in the region.

Key Points About Interchangeability

In LA, most countries lack clear regulatory guidance on interchangeability, often leaving this decision to clinicians, who may not have the necessary training or access to evidence to make informed choices. In Brazil, which is the second largest public biosimilar market, the decision on interchangeability is made between the physician and patient, with no comprehensive national guidelines yet in place. Other countries, such as Chile and the Dominican Republic, require explicit physician authorization for interchangeability.

Current real-world evidence shows that switching between biosimilars and reference products carries minimal risk, with no significant difference in immunogenicity compared with batch variations of reference products. As a result, biosimilars meeting EMA or WHO standards can be considered interchangeable unless new evidence suggests otherwise. For LA, aligning with the EMA's standards for biosimilar interchangeability and limiting switches to once annually is advised to ensure pharmacovigilance and patient safety.

Recommendations From the Panel

Using the data collected, the panel made 7 main recommendations to boost biosimilar adoption in LA:

1. Consider biosimilars approved by the EMA or following WHO guidelines as interchangeable, based on evidence, with limited switching to once a year
2. Enhance knowledge of biosimilars among health care professionals and patients to address misconceptions and promote informed decision-making
3. Establish dedicated biosimilar regulations, separate from generics, based on WHO/EMA guidelines, ensuring traceability and clear interchangeability provisions
4. Strictly enforce biosimilar regulations without exceptions for political or economic reasons
5. Provide public access to biosimilar development and evaluation data, using models like the European Public Assessment Reports
6. Develop robust pharmacovigilance systems and offer postgraduate training in pharmacovigilance to ensure proper monitoring
7. Foster collaboration between payers, policymakers, patient organizations, and industry to deliver consistent messaging on biosimilar benefits and access

“Embracing biosimilars can significantly contribute to the sustainability of health care systems, ensuring that life-saving therapies are accessible to a larger population…. Effectively communicating these benefits to stakeholders requires clear and transparent messaging, collaboration, and reliance on real-world evidence,” the authors concluded.

References

1. Castañeda-Hernández G. Espinoza MA, Pino LE, et al. Recommendations for interchangeability in a growing biosimilar market in Latin America. Adv Ther. 2024;41(12):4357-4368. doi:10.1007/s12325-024-02990-y

2. Scheinberg M, Pineda C, Castaeda-Hernndez G, et al. Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians. MAbs. 2018;10(6):827-842. doi:10.1080/19420862.2018.1484977