Xbrane And Stada Celebrate Major Milestone With EU Filing For Lucentis Rival
Xlucane Asset Joins Bioeq/Formycon FYB201 Biosimilar With EMA
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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The European Commission has approved Stada and Xbrane’s Ximluci ranibizumab biosimilar, the third Lucentis rival to be approved in the region so far. The companies are aiming to launch in early 2023 in selected European markets.
Its crunch time for sponsors of more than a dozen products as the EMA meets to adopt opinions on several marketing authorization applications.
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.