Meeting the Rigorous Demands of Biosimilar Pharmacokinetics
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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Cell-Based Assays

Learn how BioAgilytix provides the specialized large molecule insight and proven GLP / GMP knowledge needed to support a full range of cell-based assay (CBA) requirements.

Pharmacokinetics & Pharmacodynamics (PK/PD)

See how our PK expertise complements our immunogenicity services by evaluating absorption, distribution, metabolism and excretion characteristics of a product.

Case Studies

Learn why we’re a trusted partner to 22 of the top 25 global pharma and biotech companies.

Tell Us About Your Project

What are your specific assay needs? Let’s schedule a conversation to review your
questions and requirements with one of our scientists.

SPEAK TO A SCIENTIST
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