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Xbrane Hails FDA Win On ‘Streamlined’ Nivolumab Trial Program

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

 
• By Dave Wallace

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...

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