Infliximab Case Study
Infliximab is a chimeric, anti-tumor necrosis factor monoclonal antibody which is effective in patients with active rheumatoid arthritis. Infliximab is traded under the name “remicade” and is originally licensed by Janssen. It works by binding to TNF-α and inhibits the binding of TNF-α with its receptor. TNF-α is a cytokine (chemical messenger) that is involved in systemic inflammation. CT-P13 (brand name- inflectra) is a biosimilar of infliximab approved by FDA in 2016.
A Phase III randomized study to evaluate the efficacy and safety of CT-P13 compared with reference infliximab in patients with active rheumatoid arthritis: 54 week results from the PLANETRA study
Dae Hyun Yoo et al conducted a study to …show more content…
Graph8: ACR response curve for both groups Graph9: DAS28 response curves for both groups
CASE STUDY 4: RITUXIMAB & ITS BIOSIMILAR
Rituximab is monoclonal antibody used to reduce auto-immune disorders, transplant rejections, etc. Rituximab binds to CD20 proteins which are found on the surface of B cells and decrease the effectiveness of natural killer cells in killing these B cells. It destroys B cells and hence treat dysfunctional or excessive number of B cells. Rituximab was developed at IDEC Pharmaceuticals and its patent got expired in 2015.
“Physicochemical and functional comparability between the proposed biosimilar Rituximab GP2013 and originator Rituximab”
Jan Visser et al conducted a study to demonstrate the similarity among the originator rituximab and GP2013 .
Methods Involved: 1) Functional Bioassay 2)Cation exchange chromatography 3)Glycan analysis
Functional bioassays:- Using a cell based competitive binding assay, binding of rituximab to CD20 is determined. In this, test samples are used to displace fluorescently labelled rituximab from CD20. This helps to quantify Fc effector functions and ADCC