Xbrane Biopharma has withdrawn its biologics license application for a biosimilar rival to Genentech’s Lucentis (ranibizumab) in the US after the US Food and Drug Administration said it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.
Xbrane Gets US Setback For Ranibizumab Filing
BLA For Biosimilar Lucentis Rival Withdrawn As FDA Asks For More Information
Xbrane Biopharma has withdrawn the BLA for its proposed Xlucane ranibizumab biosimilar rival to Lucentis in the US after the FDA said further information was required for it to accept the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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