OBJECTIVES: The objectives of this study were to compare trends in therapeutic biologics approved by FDS, EMA and the Saudi FDA (SFDA) in the period 1996 to May 2018, and to assess differences in year of authorization and therapeutic category.

METHODS: Regulatory information for biologic license applications (BLA) authorized in the period of analysis was collected from the FDA website “Approved drug products with therapeutics equivalence evaluation” (Orange Book) and Drugs@ FDA databases, the SFDA website “Registered drugs and herbal product“ and the EMA website. Information collected included non-proprietary name, approval date, orphan designation by the FDA or EMA, biosimilar authorizations, and authorization status. Descriptive statistics were performed in the analysis

RESULTS: There were 183 therapeutic BLA authorized by FDA, EMA and SFDA in the period of 1996-2018. The FDA authorized 16 biosimilars and EMA 48. No biosimilars were registered by the SFDA. The FDA authorized 155 biologics (84 % of the total), EMA 118 (64%) and the SFDA 59 (32%). The largest number of authorizations occurred in the class of Antineoplastic and Immunomodulating Agents (n=86), followed by Alimentary Tract, Metabolism (n=16) and Blood, Blood Forming Organs(n=13). The FDA authorized first 50% of the biologics, EMA 34% and SFDA 0.5%. There were 55 biologics authorized by the three agencies, 46 by EMA and the FDA, 3 by the SFDA and the FDA, 32 only by FDA, and 20 only by EMA

CONCLUSIONS: This is the first study comparing trends in the authorization of therapeutic biologics by FDA, EMA and SFDA. The FDA authorized the largest number of biologics, and also authorized first half of those drugs. Only one third of the biologics marketed in the US or Europe were authorized by the SFDA