Enzyme-linked immunosorbent assay for the quantitative determination of antibodies to infliximab Remsima® in serum and plasma. Remsima® the world's first biosimilar mAb (approved in 2013 by EMA). The 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®) has been associated with 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 could lead to severe complications.

The Assay Genie Antibody to Infliximab® ELISA Kit can be efficiently used for monitoring infliximab anti-drug antibodies (ADA) in biological samples and is for research use only.

The Assay Genie Antibody to infliximab biosimilar (Remsima®) ELISA is a sandwich assay for the determination of antibodies against infliximab biosimilar in serum and plasma samples. During the first incubation period, antibodies to infliximab biosimilar in patient serum/plasma samples are captured by the drug infliximab biosimilar (Remsima®) coated on the wall of the microtiter wells. After washing away the unbound components from samples, a peroxidase-labelled specific conjugate is added to each well and then incubated. After a second washing step, the bound enzymatic activity is detected by addition of tetramethylbenzidine (TMB) chromogen substrate. Finally, the reaction is terminated with an acidic stop solution. The intensity of the reaction colour is directly proportional to the concentration of antibodies to infliximab in the sample.

Infliximab (Remsima®) is a chimeric monoclonal antibody and used to treat autoimmune disorders. Infliximab reduces the amount of active human tumour necrosis factor alpha (hTNF alpha) in the body by binding to it and preventing it from signalling the receptors for TNF alpha on the surface of various cell types. TNF alpha is one of the key cytokines that triggers and sustains the inflammatory reactions.

Remsima, is the world’s first biosimilar mAb (approved in 2013 by EMA). The 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. Remsima is a tumor necrosis factor alpha (TNF-alpha) antagonist used to treat rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis, adult Crohn's disease, plaque psoriasis, and psoriatic arthritis.

One of the major concern, despite of its wide usage, is potential development of anti-infliximab antibodies (ATI) which in turn may interfere with infliximab (Remsima®) efficacy as mainly judged by observing the relapse of signs and symptoms of disease and necessitate dose-escalation or potentially ending up the treatment. In this context, demonstration of anti-infliximab antibodies during treatment with infliximab (Remsima®) has a major concern and monitoring for the presence and/or quantitation of specific antibodies during clinical trials is an important issue for follow up of the treatment regimens.

The Assay Genie® ATI ELISA Kit can be efficiently used for monitoring infliximab-specific antibodies during therapy and is for research use only. With this Assay Genie® ELISA test, anti-infliximab antibodies can be detected and is for research use only.

REMSIMA is a trademark of CELLTRION, INC.