Launches of Oncology Products in LATAM vs. the United States
Author(s)
Isobel Owens-Smith1, Melissa Vargas, BS2, Brian Barley, BS2, Katherina Cordero, BS2.
1Red Nucleus, London, United Kingdom, 2Red Nucleus, Yardley, PA, USA.
1Red Nucleus, London, United Kingdom, 2Red Nucleus, Yardley, PA, USA.
OBJECTIVES: Despite increasing oncology needs in Latin America, timely access to innovative therapies remains limited. This analysis evaluates regulatory approval timelines and treatment costs for top-selling oncology products in Brazil and Argentina, compared to their initial launch in the United States, to understand the access gap across key LATAM markets.
METHODS: Ten leading oncology drugs in the U.S., such as pembrolizumab and daratumumab, were selected based on revenue rankings. Each product’s first FDA-approved indication was selected to define treatment dosing and estimate annual pricing using at launch WAC data for each country, sourced from GlobalData. Official sources (ANVISA, ANMAT) were reviewed to determine local approval dates. Time lags from FDA approval to local authorisation and annual treatment cost differentials (in USD) were calculated for Brazil and Argentina.
RESULTS: On average, oncology drugs reached Brazil 945 days and Argentina 986 days after U.S. FDA approval. Annual treatment costs were significantly lower in LATAM, specifically ~63% lower in Brazil and ~99% lower in Argentina, compared to the U.S., with an average price differential of $91,632 in Brazil and $132,941 in Argentina (mean annual cost in the U.S.: $134,933, Brazil: $50,054, and Argentina: $1,992).
CONCLUSIONS: The analysis reveals significant access delays and wide pricing disparities for oncology drugs in Brazil and Argentina versus the U.S. Access delays may diminish the clinical value of early innovations. Pricing variability suggests differences in procurement strategies, local economic constraints, and regulatory processes. These findings highlight the importance of regulatory harmonisation, early dialogue with health authorities, and value-based pricing strategies to accelerate access and improve equity in cancer care across LATAM markets. These insights can support manufacturers, policymakers, and stakeholders in shaping future access strategies that close the gap between innovation and availability in emerging markets.
METHODS: Ten leading oncology drugs in the U.S., such as pembrolizumab and daratumumab, were selected based on revenue rankings. Each product’s first FDA-approved indication was selected to define treatment dosing and estimate annual pricing using at launch WAC data for each country, sourced from GlobalData. Official sources (ANVISA, ANMAT) were reviewed to determine local approval dates. Time lags from FDA approval to local authorisation and annual treatment cost differentials (in USD) were calculated for Brazil and Argentina.
RESULTS: On average, oncology drugs reached Brazil 945 days and Argentina 986 days after U.S. FDA approval. Annual treatment costs were significantly lower in LATAM, specifically ~63% lower in Brazil and ~99% lower in Argentina, compared to the U.S., with an average price differential of $91,632 in Brazil and $132,941 in Argentina (mean annual cost in the U.S.: $134,933, Brazil: $50,054, and Argentina: $1,992).
CONCLUSIONS: The analysis reveals significant access delays and wide pricing disparities for oncology drugs in Brazil and Argentina versus the U.S. Access delays may diminish the clinical value of early innovations. Pricing variability suggests differences in procurement strategies, local economic constraints, and regulatory processes. These findings highlight the importance of regulatory harmonisation, early dialogue with health authorities, and value-based pricing strategies to accelerate access and improve equity in cancer care across LATAM markets. These insights can support manufacturers, policymakers, and stakeholders in shaping future access strategies that close the gap between innovation and availability in emerging markets.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HPR131
Topic
Health Policy & Regulatory
Topic Subcategory
Health Disparities & Equity
Disease
Oncology