11^th European Biosimilars Congress

The development pathway of a biosimilar is unlike that of a novel biotherapeutic. Many regulatory authorities reference a “step-by-step” approach to establishing biosimilarity. In the early stages there is an increased requirement for analytics.This enhanced analytical effort entails physical, chemical, and biological characterization of the biosimilar in comparison to the originator reference product. Strategies at this stage must include assessment of primary and higher-order structure as well as batch-to-batch variation for both products. If found to be “similar” during this extensive characterisation, subsequent non clinical and clinical data are then required to demonstrate the same safety and efficacy profiles as the reference. This presentation will highlight the benefit of using modern instrumental approaches to provide analytical data to support regulatory submissions. Biosimilar development requires comprehensive physicochemical structural characterization of the (glyco)protein to demonstrate “Biosimilarity” with the originator. Initially, batches of the target molecule are studied to determine the exact structure, posttranslational modifications such as glycosylation and variability of quality attributes to establish the Quality Target Product Profile (QTTP). Subsequently, comparative data for the biosimilar side-by-side with the originator is required. This includes both structural and functional activities. Strategies for primary and higher order structure determination will be discussed particularly for antibodies where their size and complexity requires LC/MS/MS approaches. Appropriate orthogonal analytical techniques for “finger-print like” assessment will be reviewed.