Session Speaker
Cell based bioassays for the validation of biosimilars: regulatory and technology bottlenecks that can impede the release of a biosimilar?
John Watson
USA

The dramatic increase in the number of new protein based therapeutics has increased the need for cell based bioassay technology that can be used to monitor product quality as well as neutralizing antibodies. Recent advances such as robust luminescent assays and commercially available pre-plated cells have significantly reduced the need for in house assay development, especially for biosimilars. The availability of high quality assays enables a quick comparison between proprietary drugs and biosimilars relative to potency and susceptibility to neutralizing antibodies. As governmental regulatory bodies refine their expectations for the validation of biosimilars it will be crucial to overcome the inherent challenges of bioassays to creat statistically valid comparative data for new biosimilars.

Selection of the appropriate assay formats and statistical algorithms can impact the speed and likelihood of drug approvals.