Biologics / Biosimilars

Biological-drug products have emerged over the past several decades and are considered to take a greater proportion in the pharmaceutical pipelines. With patent expirations, genetic pharmaceuticals 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 treatment.  

These new drugs 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.

 

These are only a few examples of what we can do. For more information, or a special request, please contact us toll free at 1-866-688-2474 or by e-mail at businessdevelopment@cirion.com.

 

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