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Xbrane Gets US Setback For Ranibizumab Filing

BLA For Biosimilar Lucentis Rival Withdrawn As FDA Asks For More Information

Executive Summary

Xbrane Biopharma has withdrawn the BLA for its proposed Xlucane ranibizumab biosimilar rival to Lucentis in the US after the FDA said further information was required for it to accept the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.

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