Xbrane Hails FDA Win On ‘Streamlined’ Nivolumab Trial Program

FDA And EMA Agreement On Opdivo Biosimilar Cuts Costs And Timelines As Firm Seeks Partner

27 Sep 2024

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.

Wooden Blocks Spelling Cost With Arrows Pointing Down — Xbrane’s plan for a single trial will reduce development costs • Source: Shutterstock

As Xbrane Biopharma continues to seek a commercialization partner for its Xdivane (nivolumab) proposed biosimilar to Opdivo, the Swedish developer has trumpeted a fresh update from the US Food and Drug Administration that will allow the firm to complete its development program faster and at a lower cost, thanks to a “streamlined” single clinical trial approach instead of separate Phase I and III trials.

Providing an update on scientific advice received from the FDA, Xbrane said the US agency “concurs with the European Medicines...