In vitro   comparative studies of biosimilar drugs

Cell and Molecular Biology Department at Selvita performs In vitro comparative studies of biosimilar insulins and insulin analogs as well as battery of various therapeutic antibodies (e.g. TNFα, VEGF and HER2 inhibitors etc.). These studies should be comparative in nature and should be designed to have appropriate sensitivity to detect relevant differences in the response to the similar biological medicinal product and the reference medicinal product. The scope of assays is in line with EMA guidelines (Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues, EMEA/CHMP/BMWP/32775/2005_Rev. 1 and Guideline on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues, EMA/CHMP/BMWP/403543/2010 ) and includes:

Insulins and insulin analogs

• Binding to both isoforms of the insulin receptor, IR-A, and IR-B, including on-off kinetics
• Activation/Autophosphorylation of both isoforms of the insulin receptor in a cell-based assay
• Three metabolic assays (glucose uptake, lipogenesis, inhibition of induced lipolysis)

Monoclonal antibodies (TNFα, VEGF and HER2 inhibitors, other)

• Binding to target antigen(s)
• Binding to representative isoforms of the relevant three Fc gamma receptors (FcγRI, FcγRII and FcγRIII), FcRn and complement (C1q)
• Fab-associated functions (battery of neutralization assays)
• Fc-associated functions (ADCC, CDC)