11 May 2021 - A tailored approach to biosimilar approvals is conceived as the next big leap for regulatory advancement in getting these drugs to market efficiently, but in both the United States and Europe there are factors slowing this advance. 

The tailored approach would do away with automatic requirements for the comparative clinical efficacy study, which has been described as a “blunt instrument” compared with analytical investigative studies that are considered more sensitive tools.

Read Center for Biosimilars article