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Xbrane Assembles The Troops As FDA Says No To Lucentis Biosimilar

Complete Response Letter Flags Two Issues, Although No More Clinical Trials Required

 
• By Dean Rudge

Xbrane Biopharma was riding the crest of a wave with the EU launch of its biosimilar to Lucentis, following years of toil and investment. However, plans to roll out the product in the US will have to be pushed back – likely – into the middle of 2025, following a US FDA complete response letter.

Denied
• Source: Alamy

Xbrane Biopharma has assembled a task force of “very experienced team members,” both from the firm and also with “external expertise,” after the Swedish pure play developer received a US Food and Drug Administration complete response letter denying approval for its proposed Xlucane (ranibizumab) biosimilar to Lucentis.

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