Regulatory authorities define biosimilars as drugs that are “highly similar” to or “interchangeable” with an approved biologic. The lack of a pre-defined path to demonstrate similarity leaves the burden of proof on the biosimilar developers. Key requirements for efficacy, quality and potency testing often require a complex set of bioassays and/or cell-based assays that are also used to assess any unwanted clinical immune response to their biosimilar. This is particularly challenging to address for biosimilars.
Commercially available cell-based assays for the development of biosimilars targeting different marketed drugs can significantly shorten development time while enabling easy adoption and greater reproducibility across multiple global sites. Examples discussed here include cell-based assays for Bevacizumab, highlighting how commercial tools can enable a biosimilar developer to move more quickly and be the first to market or submission.
Additionally, the emergence of complex human primary cell culture and co-culture in vitro models as well as biomarker-based phenotypic assays offer high-throughput and robust solutions for assessing mechanism of action and human safety and efficacy.