Xbrane Reveals Ranibizumab Refiling Plans For US
FDA Said Additional Information Was Needed To Accept Lucentis Rival BLA For Review
Xbrane has set out its plans to resubmit its application for a biosimilar rival to Lucentis in the US, after receiving details from the FDA on additional information needed for the agency to accept the BLA for review.
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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.
Having first expected to resubmit the filing by the end of this year, a delay to a key report means Xbrane now expects to deliver its new biologics license application to the FDA during Q1 2023.
Stada and Xbrane have celebrated an endorsement from the EMA’s CHMP for their Ximluci ranibizumab biosimilar rival to Lucentis. The development follows a setback for a parallel filing in the US.