The term “biosimilar” emerged in the 1980s and describes a biological product identical in all respects (dosage form, active ingredient, chemical and biological characteristics) to an original, already marketed, biological drug (vaccine, antibody, growth factor, etc.) that is no longer under patent protection.

The perfect similar nature of the two biological products in terms of safety and efficacy has to be clearly documented. Similarity evidence is gathered through new preclinical (and clinical) assays and is mandatory for the submission of a Marketing Authorization Application (MAA) to be granted by the European Medicines Agency (EMA) or the Food and Drug Administration (FDA).

For this purpose, Bioalternatives offers:

  • in vitro pharmacological functional assays suitable for evaluating the activity of biosimilars according to the target of interest;
  • Development services to adapt in vitro pharmacological assays to biosimilar evaluation specifications or to develop new assays which meet your requirements and the pathology of interest.

On request, Bioalternatives can include the assessment of additional or specific evaluations and/or calculation of specific parameters, such as:

  • Assay qualification, evaluation of interference and isotype controls, of solvent effects, etc.
  • Evaluation of precision, linearity, repeatability and reproducibility (inter- and intra-plate variation of the assay)
  • Graphical determination of EC50, EC80, EC90 for stimulating compounds, of coefficient of determination R2, of Hill number, of upper and bottom plate values
  • IC50 and Emax (efficacy) value calculation for active compounds
  • Determination of parallelism in dose-responses
  • Calculation of IC50, Emax and relative potency ratio between the biosimilar and the original biological product

Because each biosimilar project is unique, we will define together, and on a case by case basis, the project design, the number of stages, the parameters to be evaluated and the acceptance criteria, depending on each assay robustness and on your specifications.

Once the biosimilars are characterized, the selected assays can then be used for the qualification and the monitoring of the stability of the produced batches.

Related Posts or publications

Increased fatty acid synthesis inhibits nitrogen starvation-induced autophagy in lipid droplet-deficient yeast Cerulenin, a potent inhibitor of fatty acid synthase, and exogenous addition of palmitic acid could restore nitrogen-starvation induced autophagy in the absence of lipid droplets.
IL22/IL-22R pathway induces cell survival in human glioblastoma cells Interleukin-22 (IL-22) is a member of the IL-10 cytokine family that binds to a heterodimeric receptor consisting of IL-22 receptor 1 (IL-22R1) and IL-10R2. IL-22R expression was initially characterized on epithelial cells, and plays an essential rol...
Inhibition of keratinocyte differentiation by the synergistic effect of IL-17A, IL-22, IL-1α, TNFα and oncostatin M This study highlights the precise role of cytokines in the skin inflammatory response (psoriasis). IL-22 and OSM more specifically drive epidermal hyperplasia and differentiation loss while IL-1α, IL-17A and TNFα were more involved in the activation ...
Expression patterns of candidate susceptibility genes HNF1β and CtBP2 in prostate cancer: Association with tumor progression Genome-wide association studies have identified variants at multiple loci associated with prostate cancer (PCa) risk. Some of these loci include candidate susceptibility genes, such as MSMB, HNF1β, and C-terminal-binding protein (CtBP2). Except for M...
Contribution of IL22 to experimental skin inflammation Focused on in vitro human models, we present the mechanisms of action of IL22 as well as its involvement in structure, metabolism, differentiation, chemotaxis, antibacterial activity, innate immunity, and tissue remodeling of epidermis.