FDA and EMA Biosimilar Approvals.

METHODS Sixteen biosimilars of 9 originator biologics had been approved by both the FDA and the EMA by February 2019 (the infliximab biosimilar Ifixi was FDA- but not EMA-approved). FDA and EMA approvals were based on 20 and 22 clinical trials, respectively, about two-thirds of which (FDA, 65%; EMA, 64%) were phase I trials. Two were approved without a phase II or III trial: the filgrastim biosimilar Nivestym (FDA) and the pegfilgrastim biosimilar Udenyca (FDA/EMA). [Extracted from the article]