Accessibility of Biologic Drugs in Morocco: Comparison with FDA and EMA Approvals (2015–2025)

Abstract

This study aims to evaluate the rates and timeframes of the availability and reimbursement of biologic drugs in Morocco, after approval by the Food and Drug Administration (FDA) or the European Medicines Agency (EMA). The results will help to identify disparities in access and promote rapid access to these innovative treatments. This descriptive study established an international reference list of biological medicines, based on data from the FDA and EMA for the period from 2015 to 2025. An analysis was conducted using national sources, focusing on the availability, reimbursement rates, and timeframes for each listed biological drug. Of the 233 listed biological drugs, only 13.7% (32/233) of those approved between 2015 and 2025 are available in Morocco. Of these, 87.5% (28/32) have been priced, and only 10.7% (3/28) have been approved for reimbursement. The average time between FDA/EMA approval and pricing in Morocco is 3.75 years and 3.41 years, respectively, while the average reimbursement approval time is 2.74 years. This study highlights the delay and limited access for Moroccan patients to internationally approved biologic drugs.