Enzyme immunoassay for the quantitative determination of antibodies to infliximab Remsima® in serum and plasma.
Remsima®, the world first biosimilar mAb (approved in 2013 by EMA). The Agencys Committee for Medicinal Products for Human Use(CHMP) decided that, in accordance with EU requirements, Remsima® has been shown to have a comparable quality, safety and efficacy profile to Remicade. Infliximab (Remsima®) was associated to the development of anti- Infliximab antibodies, even some were reported to be neutralizing, in various percentages of patients during therapy with the drug Remsima®. This might lead to severe complications. The Matriks Biotek Shikari®Antibody to Infliximab®ELISA Kit can be efficiently used for monitoring anti- Infliximab antibodies during therapy and offers the clinician a tool for decision on possible preventive measures such as possible addition of immunosuppressive drug to reduce anti- Infliximab antibodies.