Biogen Partners with Theradiag on Biosimilar Infliximab Monitoring Kits

Theradiag, a French company that specializes in in vitro diagnostics and theranostics (targeted therapy based on targeted diagnostic tests), has entered into a partnership agreement with Biogen to provide its Lisa Tracker kits to monitor patients treated with Biogen’s infliximab biosimilar Flixabi, which was approved in Europe in 2016.

The partnership will allow Biogen to supply Lisa Tracker monitoring kits in France and other European countries to optimize the treatment of patients receiving the biosimilar. Flixabi is indicated for the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriasis, and psoriatic arthritis. Under the agreement, Theradiag will be Biogen’s preferred supplier of infliximab monitoring kits. Theradiag will also handle implementation, provide training to laboratories in how to use the kits, and follow up on clinician requests concerning monitoring.

Lisa Tracker kits are used to monitor patients taking biotherapies for diseases ranging from gastroenterology, rheumatology, and dermatology to oncology. The kits allow clinicians to simultaneously monitor patients’ trough plasma levels of 3 parameters within 3 hours of reaction from a serum sample in order to anticipate, optimize, and better manage patients’ treatment with infliximab:

• The amount of circulating tumor necrosis factor (TNF) alpha, one of the main markers involved in the inflammatory process
• Levels of prescribed anti—TNF-alpha drugs (infliximab, adalimumab, etanercept, certolizumab pegol, and golimumab), helping to optimize drug dosage consistent with the presence or absence of anti-drug antibodies (ADAs)
• The presence of ADAs directed against medication, which may be present in patients experiencing loss of drug efficacy

Consensus statements support therapeutic drug monitoring (TDM) used to guide and optimize anti-TNF therapy in IBD, particularly in situations of treatment failure. One such statement, issued by the Australian Inflammatory Bowel Disease Consensus Working Group and other international experts, recommended TDM of anti-TNF agents upon treatment failure, following successful treatment induction, and when contemplating a drug holiday.

However, the group said there is inconsistent evidence for proactive TDM, and therefore advised that TDM should be performed for patients in stable remission only if results are likely to impact clinical management.