During a presentation given by Dr Carmine Lanni (Biologics Development Services, USA) bioanalytical challenges in the development of biosimilars were discussed [1]. While there are clear guidelines for bioanalytical methods, such as those from the European Medicines Agency (EMA), there are few recommendations for the development and validation of bioanalytical assays to support nonclinical and clinical studies for biosimilars.

One of the challenges highlighted for the development of such assays was the procurement of high-quality assay reagents, such as coating antibodies or target antigens. The assays used by the originator company may be antiquated, unknown or even patent protected.

Another major challenge is the significance of the glycosylation state of the biosimilar in comparison to the reference product. This can have a major impact on whether the calibration curves of the biosimilar and reference product are highly similar. The glycosylation state of a biosimilar can be influenced by many different steps in the production process used to generate a given molecule, e.g. cell culture conditions, and manufacturing or finishing processes.

The conclusion was that in order to produce high quality bioanalytical data for both the biosimilar and reference product using the same calibration curve, the %CV and total relative error must be assessed more stringently than current regulatory recommendations suggest.

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Reference

1.  Colletti KS. Conference Report: Bioanalysis-related topics presented at the International Conference and Exhibition on Biowaivers and Biosimilars. Bioanalysis. 2013;5(5):529-31.

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