Abstract
Infliximab reference product and two biosimilar products were approved by the Saudi Food & Drug Authority (SFDA) for the treatment of a wide variety of inflammatory conditions such as rheumatoid arthritis, Crohn's disease, and ankylosing spondylitis. Recording both the product trade name and the batch number are essential in the spontaneous reporting of adverse drug events (ADEs) of biological medicines due to the variability of the bio-manufacturing process that may cause safety risks such as immunogenicity. This study aims to assess the availability of batch number and trade name in the ADE reports of Infliximab (reference product) and biosimilar products in the National Pharmacovigilance Center (NPC) database at SFDA.
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