Unprecedented Post-Approval Production Cell Line Change of a Bevacizumab Biosimilar with the NMPA

An unprecedented post-approval production cell line for a bevacizumab biosimilar is presented. Cell line changes are considered to have a relatively high potential risk to product safety and efficacy. Therefore, such changes are often done before pivotal studies during clinical trials. The post-approval regulatory pathway for significant cell line changes is often ambiguous. There are currently no published examples of a post-approval cell line change. This case study demonstrates a three-way analytical and non-clinical comparability study strategy, which utilizes sophisticated analytical methods, allowing successful approval of a post-approval cell line change with the NMPA.