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Xbrane Refiles Ranibizumab With US FDA

Firm Is Eyeing H1 2024 Approval For US Biosimilar Rival To Lucentis

 
• By Dave Wallace

Xbrane has resubmitted its filing for a ranibizumab biosimilar version of Lucentis to the FDA, suggesting that it could receive approval in the first half of next year.

Sign outside of FDA's headquarters in White Oak, MD
Xbrane’s ranibizumab filing is once again with the FDA • Source: Alamy

Almost a year after having its filing for a Lucentis (ranibizumab) biosimilar knocked back by the US Food and Drug Administration, Xbrane Biopharma has resubmitted the biologics license application to the US regulator.

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