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Xbrane Gets US Setback For Ranibizumab Filing

BLA For Biosimilar Lucentis Rival Withdrawn As FDA Asks For More Information

 
• By Dave Wallace

Xbrane Biopharma has withdrawn the BLA for its proposed Xlucane ranibizumab biosimilar rival to Lucentis in the US after the FDA said further information was required for it to accept the filing. Development partner Stada said it would “work closely” with Xbrane and US licensee Bausch + Lomb to get the product to market.

Sign outside of FDA's headquarters in White Oak, MD
The FDA has requested more information on the Xlucane filing • Source: Alamy

Xbrane Biopharma has withdrawn its biologics license application for a biosimilar rival to Genentech’s Lucentis (ranibizumab) in the US after the US Food and Drug Administration said it would need more information to accept the filing.

The product, developed under the name Xlucane, is one of Xbrane’s leading biosimilar candidates. The Swedish firm has collaborated with Stada to develop the product, while Bausch + Lomb has licensed US and Canadian marketing rights

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