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Xbrane And Stada Celebrate Major Milestone With EU Filing For Lucentis Rival

Xlucane Asset Joins Bioeq/Formycon FYB201 Biosimilar With EMA

Executive Summary

Xbrane Biopharma has taken a key step on its journey to begin generating cash from operations by early 2024 at the latest, after its Xlucane biosimilar ranibizumab asset was submitted to the European Medicines Agency by co-development and commercialization partner Stada.

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Xbrane Reveals Ranibizumab Refiling Plans For US

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Xbrane Biopharma has withdrawn the BLA for its proposed Xlucane ranibizumab biosimilar rival to Lucentis in the US after the FDA said further information was required for it to accept the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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Stada has announced the appointment of former Sandoz executive Christine Berndt as head of global development for specialty and biosimilar products, replacing Michael Mack.

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