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The Third Time’s The Charm? Xbrane Resubmits Ranibizumab In US

Follows Two Previous Knockbacks From FDA Over Lucentis Biosimilar

 
• By Dave Wallace

Xbrane is taking a third shot at filing its ranibizumab biosimilar rival to Lucentis with the US Food and Drug Administration. Will it succeed where it has previously failed to gain approval?

Xbrane has resubmitted its Lucentis rival to the US FDA (Shutterstock)

Xbrane Biopharma will be hoping that the third time is the charm for its proposed US biosimilar to Genentech’s Lucentis (ranibizumab). Having already filed a biologics license application for the candidate twice with the US Food and Drug Administration and been knocked back both times, the Swedish biosimilars developer is now making a third attempt to gain approval for the ophthalmic treatment.

An initial US filing for Xbrane’s ranibizumab candidate had been withdrawn back in May 2022 after the firm received “feedback from the FDA that complementary information is required for...

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