Randomised clinical endpoint studies for trastuzumab biosimilars: a systematic review.

The pivotal data for each marketing approval was not the randomised clinical endpoint study, but the in vitro analytic characterisation. Regulatory confidence in in vitro analytic characterisation stems from years of experience with manufacturing changes for originator biological medicines. This emphasis on in vitro data, as the most sensitive way to detect clinically important differences, will be a new way of thinking for many oncologists.