PRICE ANALYSIS OF ONCOLOGY BIOLOGICS AND BIOSIMILARS IN SAUDI ARABIA: A CROSS-SECTIONAL STUDY (2015-2025)
Author(s)
Esraa Almudaiheem, PharmD, MSc1, Ahmed Alghamdi, BSc, PharmD, PhD2, Mohammad Alowairdhi, MBA, MSc1, Sultan A. Al-Harbi, EMBA1.
1Saudi FDA, Riyadh, Saudi Arabia, 2King Saud University, Riyadh, Saudi Arabia.
1Saudi FDA, Riyadh, Saudi Arabia, 2King Saud University, Riyadh, Saudi Arabia.
OBJECTIVES: Expensive oncology therapeutics strain healthcare systems globally. In Saudi Arabia, the Saudi Food and Drug Authority (SFDA) employs regulatory pricing mechanisms to balance affordability and access. This study analyzes pricing trends of oncology biologics and biosimilars to identify key cost drivers and benchmark against international markets.
METHODS: A cross-sectional study was conducted to include 53 oncology biologic and biosimilar products registered with the SFDA between 2015 and 2025. International ex-factory prices were sourced from GlobalData for 14 available reference countries. For all datasets, descriptive statistics, Mann Whitney and Kruskal-Wallis tests were performed to compare between prices by product type, dosage form, and pharmacological classes. Analyses were conducted using excel and R.
RESULTS: Biologics showed greater price reductions than biosimilars (p = 0.016). No difference existed between IV and SC products. Significant price variations across pharmacological classes (p = 0.002), with immuno-oncology demonstrating higher price distributions. Overall, Saudi Arabia showed a modest mean price reduction of -3.75%, driven by regulatory renewals (87.5%) and GCC price unification (12.5%). The average cost per year was 364,944.20 SAR. International trends were heterogeneous, with slight price increases in some countries (e.g., Austria, Sweden) and notable reductions in others (e.g., France, Australia).
CONCLUSIONS: SFDA’s interventions effectively stabilize prices. Greater biologic price reductions suggest competitive responses to biosimilar entry. Price disparities across classes and high annual costs highlight areas for targeted policy. These findings advocate for continuous monitoring, refined pricing strategies, and strengthened benchmarking to ensure sustainable oncology care in Saudi Arabia.
METHODS: A cross-sectional study was conducted to include 53 oncology biologic and biosimilar products registered with the SFDA between 2015 and 2025. International ex-factory prices were sourced from GlobalData for 14 available reference countries. For all datasets, descriptive statistics, Mann Whitney and Kruskal-Wallis tests were performed to compare between prices by product type, dosage form, and pharmacological classes. Analyses were conducted using excel and R.
RESULTS: Biologics showed greater price reductions than biosimilars (p = 0.016). No difference existed between IV and SC products. Significant price variations across pharmacological classes (p = 0.002), with immuno-oncology demonstrating higher price distributions. Overall, Saudi Arabia showed a modest mean price reduction of -3.75%, driven by regulatory renewals (87.5%) and GCC price unification (12.5%). The average cost per year was 364,944.20 SAR. International trends were heterogeneous, with slight price increases in some countries (e.g., Austria, Sweden) and notable reductions in others (e.g., France, Australia).
CONCLUSIONS: SFDA’s interventions effectively stabilize prices. Greater biologic price reductions suggest competitive responses to biosimilar entry. Price disparities across classes and high annual costs highlight areas for targeted policy. These findings advocate for continuous monitoring, refined pricing strategies, and strengthened benchmarking to ensure sustainable oncology care in Saudi Arabia.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HPR17
Topic
Economic Evaluation, Health Policy & Regulatory
Topic Subcategory
Pricing Policy & Schemes
Disease
Oncology