(9) Traceability of Insulin Glargine's Innovator and Its Biosimilar Products Adverse Drug Events Reports in Saudi Arabia

Sunday, August 28, 2022

8:00 AM – 1:45 PM CEST

Location: Hall C

Publication Number: 1054

Presenting Author(s)

Fares Alrubaish
– Saudi Food and Drug Authority, Riyadh, Al Riyadh, Saudi Arabia

Co-Author(s)

Solaiman Alhawas
– Saudi Food and Drug Authority, Saudi Arabia
Abdulrahman Alnuaim
– Saudi Food and Drug Authority, Saudi Arabia
Nouf Alfadel
– Saudi Food and Drug Authority (SFDA), Ar Riyad, Saudi Arabia
Fawaz F. Alharbi, MSc, PhD.
– Saudi Food & Drug Authority (SFDA), Saudi Arabia

Background: Insulin glargine’s innovator and two biosimilar products are approved in Saudi Arabia to improve glycemic control in adults and children age 2 years and above with diabetes mellitus. The identification of brand name and batch number are essential components in reporting adverse drug events (ADEs) of biological medicines due to the variability of biomanufacturing process that may cause safety risks such as immunogenicity.

Objectives: To assess the availability of batch number and tradename of reported insulin glargine (reference and biosimilar) ADEs to the National Pharmacovigilance Center (NPC) database.

Methods: We performed a descriptive analysis of spontaneous ADE reports of insulin glargine (reference and biosimilar) in Saudi Arabia reported to the NPC from January 1, 2010 to January 10, 2022. The analysis examined the reporting frequency of batch number, and tradename.

Results: The study identified 410 ADE reports of insulin glargine. There were 368 (89.8%) reports linked to innovator product, 30 (7.3%) reports linked to biosimilar product. The remaining (11; 2.7%) reports did not include the tradename. The batch number was included in 216 (52.7%) of reported cases. 215 (52.4%) ADE reports included both the batch number and the tradename. The majority of cases did not indicate the reporter type (300; 73.2%). The remaining 110 ADE reports were submitted by a healthcare professional, of which, 41 (37.3%) included both tradename and batch number, 67 (60.1%) included on only the tradename, and 2 (1.8%) reports did not include the tradename or batch number.

Conclusions: The analysis demonstrates limitation of spontaneous ADE reports of insulin glargine (reference and biosimilar) due to not including batch number of the reported ADEs. It is essential to raise awareness of healthcare providers and the public in order to improve data completeness of biologic and biosimilar products’ spontaneous ADE reports.