Abstract

Rapid growth of the market for biosimilar products is expected in the next few years, as the patents for a large number of approved biologics are about to expire. This has incited a race to get approval for newly developed biosimilars. Prior to biosimilar approval for entering the biotherapeutic market, pharmacokinetic analysis and demonstration of bioanalytical comparability and similarity between the biosimilar and the reference product (originator) are required by regulating agencies in support of non-clinical and clinical studies. To meet this objective, it is critical to develop a robust assay that is able to quantify the biosimilar and reference product within the assay range in a head to head manner. The developed method must be validated to establish the reliability of the method to consistently, accuratelyand precisely measure the concentration of the biosimilar and the reference product in the relevant biological matrix. This article discusses important aspects of biosimilar PK assay development and validation, and presents regulatory issues concerning biosimilar PK.

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