Pre-qualified GLP-compliant assays for biosimilars – fast track assays

Craig Draper, PhD, Director of Commercial Operations, Eurofins Pharma BioAnalytics Services, CraigDraper@eurofins.com

Large molecule generics, often referred to as biosimilars or follow-on biologics, are a major focus of drug development activities. As patents on many major biologics are expiring, it is estimated that $67B of the innovator drug sales will be open for biosimilar competition to 2019.

Biopharmaceutical companies developing biosimilars must prove that their version of the drug is similar to the original, or innovator molecule. In assessing the comparability of proposed biosimilar compounds to the innovator counterparts, regulatory agencies have stressed the “totality-of-evidence” approach, which relies on both structural and functional characterisation, as well as data from animal and clinical studies. Eurofins Bioanalytical Services has developed a suite of pre-qualified assay methods for biosimilars trastuzumab, adalimumab, bevacizumab, rituximab and cetuximab. These assays provide drug developers rapid access to clinical and characterisation data, and as core assays are prequalified, the development costs and time are typically half those of full validation using de novo methods.

Clinical Assays include pharmacokinetic (PK) and anti-drug antibody (ADA) assays. These tests are prequalified, using innovator standards and calibrators.

Eurofins scientists consult with Sponsors who can provide additional biosimilar-specific reagents to further validate the assays to the specific needs of the study. Eurofins can follow both the “one assay” and “two assay” approach to provide flexibility for Sponsor study requirements.

Target binding and Fc receptor binding assays are performed using Biacore™ SPR systems using qualified reagents and methodology. Addition of the Sponsor supplied biosimilar enables rapid validation and analysis. C1q testing by ELISA and ADCC assays further expand the characterisation services available.

The assay sets can be run individually or as a package. Bioanalytical and characterisation packages are tailored to meet the distinct needs of biosimilars developers ensuring accuracy, adherence to standards and on-time delivery of critical data, no matter the size of project.

For more information, visit: http://www.eurofins.com/biopharmaservices/ bioanalysis/biosimilars/