The biotechnology (Biotech) pharmaceutical area is undergoing dramatic growth and demanding greater levels of service. As a biotech contract research organization (CRO), Sinclair Research is familiar with follow-on biologics studies, or biosimilars, including biocomparability human and veterinary products. FDA biosimilars pathway rules allow acceleration of product licensing if similar biochemistry can be shown for a new biological product when compared to an earlier reference product. Biotech pharmaceutical products, new biologic entities (NBE), including monoclonal antibodies, small and large protein drugs, oligonucleotide products, and DNA vaccines make up the biotech class of drugs.


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