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Pharmacokinetic assessment of biosimilar therapeutic monoclonal antibodies

04:02 EDT 10 May 2019 | Generics and Biosimilars Initiative

Comparison of the clinical pharmacokinetic (PK) profile of a biosimilar with that of the reference product is an important step in the development of biosimilars. In a recent review, Ishii-Watabe and Kuwabara outline key considerations for the comparative studies required for biosimilar development, focusing on the clinical PK profiles of biosimilar therapeutic monoclonal antibodies (mAbs) and their reference products [1].

Original Article: Pharmacokinetic assessment of biosimilar therapeutic monoclonal antibodies

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