The Importance of Biosimilar Testing

Biosimilars are a class of drug that are very similar, though not identical, to brand name biologics (also called a reference product). These minor biochemical differences between a biosimilar and its reference product, can result in differences in the pharmacokinetics and immunogenicity, and in turn, safety and efficacy differences. 

Biosimilars offer a potentially cheaper treatment option than some brand-name biologics as they have an abbreviated FDA approval process. However, bioanalytical, immunogenicity, and pharmacokinetics studies of biosimilars are typically required for approval. With nine biosimilars currently approved by the FDA (as of 2018) and several large pharmaceuticals investing in the biosimilars market, it is estimated that the number of biosimilars being developed is going to increase dramatically.

Our bioanalytical experts have regulatory expertise in product characterization, pharmacokinetics and immunogenicity, for both brand-name biologics and biosimilars. Our experience can help with any of your biosimilar testing challenges and take your biosimilar from discovery phase through Phase III studies and beyond.

Our Assays For Biosimilar Development & Testing

Eurofins companies have years of experience supporting biologics and biosimilars programs, including monoclonal antibodies, metabolic hormones and immunomodulatory drugs, making us your ideal partner for bioanalytical services. Following the latest U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMEA) regulations and guidance, we tailor bioanalytical and characterization packages to meet your distinct biosimilar development needs. We use the latest technologies and procedures to ensure accuracy, adherence to standards and on-time delivery of critical data, no matter the size of project.

Our diverse set of analytical methods help you to evaluate comparability of both the biosimilar drug and its clinical performance. We develop customized assays for exploratory or GLP biosimilar comparability testing, including:

Non-clinical services

• Pharmacokinetics
• Tiered immunogenicity
• Biomarkers

Biological Characterization Services

• Ligand-binding and cell-based assays for target proteins
• CD64, CD32, and CD16 binding
• C1q binding
• Proliferation, neutralization, and receptor binding assays
• Antibody-dependent cell-mediated cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC)

Prequalified assays for:

• Trastuzumab
• Bevacizumab
• Adalimumab
• Cetuximab

We have leading experience using the several instruments and platforms for conducting immunogenicity and PK studies, biomarker studies, cell-based assays to support the development of biosimilars. Whether we are helping you develop and validate assays, analyze samples, or transferring previously developed methods, Eurofins can deliver high quality data suitable for regulatory submission.

Learn More About The Instruments We Use

Our Biosimilars Philosophy

Assessing the difference between a biosimilar and a brand-name biologic is a complex issue, which presents different challenges for every biosimilar. Therefore, there is no “one size fits all” way to do biosimilars analysis. Eurofins has extensive experience with immunogenicity testing, PK, and biosimilar comparability studies and our expertise in the development of biologics and biosimilars can help you find the optimal solution for your biosimilar. 

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Expertise in simple and complex biosimilars

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