Biologics / Biosimilars

Biological-drug products have emerged over the past several decades and are becoming a larger sergment of pharmaceutical pipelines. CIRION is an expert in assay development and validation fornumerous types of biologics.  

With patent expirations, generic pharmaceutical companies are moving into this new marketplace. The term for generic biological-drug products currently used is either "follow-on" biologics or "biosimilars". Based on the fact that these drug products (biologics and biosimilars) can induce an immune response to the patient, regulatory agencies are focusing on immunogenicity testing to ensure patient safety and efficacy of the treatment.   

These new drug products (biologics and biosimilars) need to be measured after administration through PK studies to determine the behaviour of the drug and through immunogenicity studies to determine the presence of antibodies.


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