Biosimilars are officially approved versions of biological medicinal products, closely resembling their originators, for which patent protection expired. Unlike generics, biosimilars are expected to show naturally occurring differences caused by development and manufacturing process. The registration process requires body of evidence that biosimilar drug is comparable (EMA) or similar (USA) to its originator in terms of physicochemical properties, structure, and potency.

In recent years Selvita completed several in vitro comparative studies of biosimilar insulins and insulin analogues, as well as battery of various therapeutic antibodies (e.g., TNFα, VEGF and HER2 inhibitors etc.). These studies are designed to hold appropriate sensitivity to detect relevant differences between the similar biological medicinal product and the originator. The assays scope 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 analogues

  • 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)