Mayo Clinic has completed validation of its existing Infliximab Quantitation with Reflex to Antibodies to Infliximab, Serum test for the new biosimilar drug Inflectra. Clients can now submit specimens from patients on Inflectra in the same way specimens are submitted when patients are taking Remicade. No changes to existing processes and no additional information are required. Infliximab (Remicade) is used to treat inflammatory bowel disease, as well as other inflammatory diseases such as rheumatoid arthritis. Mayo Medical Laboratories’ test measures the patient’s concentration of the drug and, if low, reflexes to a further test to determine whether the patient is producing antibodies to the drug. Inflectra (infliximab-dyyb) is a biosimilar to Infliximab. A biosimilar is a biological product that is FDA- approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Biosimilars typically offer a significant price advantage to patients.

According to Melissa Snyder, Ph.D., Director of Mayo Clinic’s Antibody Immunology Laboratory, “It is important to know that existing laboratory tests for both the drug and the anti-drug antibodies are validated for the new formulations as more biosimilars are approved by the FDA.”