Inflectra® | Safety Profile & Efficacy
Inflectra®, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:
• Adult patients with active disease when the response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate2.
• Adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs2.
*CT-P13 is marketed under different brand names including INFLECTRA® and REMSIMA®.
§EMA guidelines state that “Extrapolation of clinical efficacy and safety data to other indications of the reference mAb, not specifically studied during the clinical development of the biosimilar mAb, is possible based on the results of the overall evidence provided from the comparability exercise and with adequate justification.”1,3.
EMA, European Medicines Agency; mAb, Monoclonal antibody
PP-IFA-GBR-0465. December 2020