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.