OBJECTIVES: Therapeutic biologics are produced in living cell cultures or through genetic engineering of proteins. Therapeutic biologics have been approved for treatment of multiple diseases, including rheumatoid arthritis, multiple sclerosis, Crohn’s disease, psoriasis, psoriatic arthritis, asthma, chronic pain, and cancer. The objectives of this study were to assess trends in therapeutic biologics registered by the Saudi FDA (SFDA) in the period January 1989 to May 2019

METHODS: Regulatory information for biologic license applications (BLA) registered by the SFDA in the period of analysis was collected from the SFDA website “Registered drugs and herbal product.” Information collected included BLA number, brand and non-proprietary names, form, strength, registration date, legal status, marketing company, and authorization status. Descriptive statistics were performed in the analysis.

RESULTS :The SFDA registered 66 therapeutic biologics products with a total of 109 different formulations/strengths in the period of 1989-2019. There were 5 biologics (7.5% of the total) registered in the period of 1989-1994, 1 (1.5%) in 1995-1999, 4 (6.06%) in 2000-2004, 5 (7.5%) in 2005-2009, 13 (19.6%) in 2010-2014, and 38 (57.5%) in 2015-2019. The largest number of registrations occurred in the class of Antineoplastic and Immunomodulating Agents (n=47), followed by Blood, Blood Forming Organs (5) and Alimentary Tract, Metabolism (4). All the approved biologics had parenteral route of administration

CONCLUSIONS:There was a substantial increase in the number of therapeutic biologics registered by SFDA in the period 1989- 2019. Most of the registrations occurred in the past 4 years.