Biosimilar is a term used for a biopharmaceutical which produces a preferred and similar pharmacological, biochemical activity or effect as compared to a biological or biopharmaceutical which is approved by FDA.
in order to get an FDA approval for a biological product as biosimilar or as interchangeable biopharmaceutical a manufactures is required to provide data as evidence demonstrating that the biological product is highly similar to a previously approved biopharmaceutical.Biological product or biopharmaceutical consist of vaccines, tissue cultures, allergenic , gene therapy , stem cell therapy products.
To get an approval as biosimilar or interchangeable biological product , proposed product is required demonstrate and establish stepwise similarity with an existing approved biological product with respect to , animal toxicity, structure, (PK) human pharmacokinetics , pharmacodynamics , efficacy and clinical safety.
Biosimilar products are similar to approved biological product but may not be exactly same with respect to their components and constituents.
This is done through , step wise approach .
1) Establishing structural similarity , by amino acid sequence, Enzymatic post translational modifications, like glycosylation , phosphorylation, and other modifications like PEGylation and its sites of PEGylation.
2) Functional Assay , Analytical validations
3) Animal Toxicity Studies , Animal Immunogenicity Studies, Clinical Immunogenicity Assessment and so on.
In case of chemical drug molecules which are approved as a generic drug, their molecular structures and chemical pathways for synthesis are more or less similar to the patented and approved drug. Therefore by adapting available pharmacopeia monographs for testing procedures and standards its efficacy and safety can be controlled easily, it can be done by evaluating its bioequivalence and bioavailability studies.
Where as in case of biological preparations the pathways and mode of synthesis of a biopharmaceutical may vary from manufacturer to manufacturer as the original patented biopharmaceutical manufacturers cell lines or tissue cultures, microorganism cultures may differ, this imparts great variation in manufacturing and purification process compared to an already approved biopharmaceutical and prospective biosimillar bio-pharmaceutical.
Therefore best way to assess the safety and efficacy of a interchangeable or biosimilar biological product which is to asses its effect on biological systems or its pharmacological effects, it may include evaluation of impurities which may give raise to allergenic reactions and the dosage frequency and amount of dose required to gain desired effect as compared to an approved biopharmaceutical by FDA.
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