Case Studies: Challenges of Supporting Comparability Work for Biosimilars

Abstract

Establishing biosimilarity of a biosimilar drug to its originator presents unique challenges as compared with small-molecule generic drugs. In addition to assessing structural and chemical characteristics of the molecule, its efficacy and safety must also be compared with its originator through pre-clinical and clinical comparability studies. Therefore, it is critical to develop and validate PK bioanalytical assays, which can assess biosimilar and originator, as well as their anti-drug antibodies ‘similarly’ in biological matrices.

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Cell-Based Assays

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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 (PK) Services

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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