SUMMARY  

• TREMFYA (guselkumab) is a product of Janssen Biotech, Inc. Please refer to local labeling for relevant information describing guselkumab and for a complete list of ingredients.
• Guselkumab is a fully human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody that binds selectively to the extracellular human interleukin 23 (IL-23) protein with high specificity and affinity.¹
• Guselkumab is produced in a mammalian cell line using recombinant DNA technology.¹
• Guselkumab was isolated from a fully synthetic human fragment of antigen binding (Fab) library by phage display selection. This proprietary antibody library technology was developed by MorphoSys AG and called Human Combinatorial Antibody Library (HuCAL) GOLD^®.^2-4
• The excipients of TREMFYA have no ingredients from animal or human origin present.⁵
• The substances used in the manufacturing process of guselkumab drug substance are not from animal origin or certification is given from suppliers that substances are in compliance with guidelines established by the Note for Guidance on Minimizing the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products.⁶

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent^® (and/or other resources, including internal/external databases) was conducted on 28 January 2025.