Monoclonal Antibody and Fusion Protein Biosimilars

Description :

Regulatory efforts to formalize guidance policies on biosimilars, there remains a need to educate healthcare stakeholders on the acknowledged definition of biosimilarity and the data that underpin it. A number of biologics are fusion proteins in which the extracellular domain of a receptor has been fused with the Fc region of an immunoglobulin, usually a human IgG1, to generate a soluble form of the receptor. Etanercept is the best recognized example in rheumatologic practice because it is a soluble form of the p75 tumor necrosis factor (TNF) receptor that can bind and neutralize TNF Fusion proteins are relatively simple to design and can exploit the ligand redundancy of certain receptors, providing a broader specificity than antiligand or antireceptor mAbs.