OBJECTIVES: Therapeutic biologic products (BLA) are produced in living cell cultures or through genetic engineering of proteins. The FDA BLA definition excludes allergenics, blood products, cellular and gene therapy, tissue products, and vaccines. This study assessed trends in BLAs licensed by the FDA and the European Medicines Agency (EMA) in the period 1995-2014. METHODS: Regulatory information for BLAs was derived from the agencies webpages. We extracted data for BLAs approved before the establishment of the EMA licensing process from the UK Medicines and Healthcare products Regulatory Agency (MHRA). Insulins and some hormones that are approved by the FDA using the drug application system, were excluded from analysis. BLA were classified using the WHO anatomical therapeutic chemical classification. Descriptive statistics and chi-square tests were conducted in the study. RESULTS: