As patents on popular biological medical products begin to expire, there is an emerging need for reliable testing capabilities to support biosimilar development.

Regulatory guidance recommends that extensive and robust comparability studies be performed on both physicochemical and functional attributes between the biosimilar product and its respective reference/innovator product.

The network of Eurofins BioPharma Product Testing laboratories globally is proactively expanding our offering of validated cell based potency assays that are ready to use to test biosimilar drug substance and drug product samples, as well as to assist process development and validation.