In October 2024, FIFARMA unveiled the third edition of its W.A.I.T (Waiting to Access to Innovative Therapies)Indicator report analysing the time it takes for innovative medicines to become accessible in Latin America.
The report examines access to innovative medicines in Latin America across five therapeutic areas: oncology, orphan diseases, immunological and inflammatory diseases, central nervous system, and cardiometabolic diseases. It monitored 365 treatments approved by the US Food and Drug Administration (FDA) or European Medicines Agency (EMA) between 2014–2023, representing 80% of new active substances globally during this period. The analysis covered 10 countries: Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, Mexico, Panama, Peru, and the Dominican Republic.
The key findings of the report were:
- Limited availability:
- Only 61% of internationally approved medicines have regulatory approval in at least one Latin American country, and 35% have partial or full public availability.
- For treatments approved since 2020, availability drops to less than 12%, highlighting slow access to recent innovations.
- Long wait times:
- On average, it takes 4.75 years for a new drug to become publicly available in Latin America after FDA or EMA approval.
- Treatments approved in October 2024 would likely reach public health systems only by August 2029.
- Delays in critical areas:
- Treatments for orphan and oncological diseases are particularly delayed, with 87% showing no progress in regulatory approval or public access from 2023 to 2024.
- Country-specific delays:
- Countries like Colombia, Chile, and Mexico exceed the regional average, with approval and reimbursement processes taking over five years.
The podcast Innovatibles brought attention to the key findings of this report. The discussion highlighted the average five-year wait for new medicines in Latin America. Costa Rica leads with swift approvals, while Mexico and Colombia face longer delays. The report categorizes drug availability into full, limited, private insurance only, and no availability. Only 35% of approved drugs are publicly available. Orphan drugs, though approved faster, face significant hurdles in reaching patients. The innovation squeeze means newer drugs are less accessible.
Positively, 13% of drugs improved availability between 2023 and 2024. The conversation emphasized the need for systemic changes to bridge the gap between medical innovation and patient accessibility.
According to the World Health Organization, it is very important to improve access to biotherapeutic products and ensuring their quality, safety and efficacy. In 2014, it adopted a resolution recognizing them as biotherapeutic products similar to reference medicines. Biosimilars are developed after patents expire, this substantially reduces costs and improves availability and access to treatment for a greater number of patients [1].
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Recommendations for improving biosimilar regulations in Latin America
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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Benefits of innovative biologicals and biosimilars for patients and health systems [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Feb 18]. Available from:
www.gabionline.net/reports/benefits-of-innovative-biologicals-and-biosimilars-for-patients-and-health-systems
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