Xbrane Hails FDA Win On ‘Streamlined’ Nivolumab Trial Program
FDA And EMA Agreement On Opdivo Biosimilar Cuts Costs And Timelines As Firm Seeks Partner
Executive Summary
Xbrane says scientific advice from the US FDA on a “streamlined” clinical program for its proposed nivolumab biosimilar, comprising just a single trial, will cut the development costs and timeline for the Opdivo rival, making it more attractive as Xbrane seeks a commercialization partner.