Xbrane Data Sets Up EU And US Ranibizumab Filings
Filing Dates Confirmed For Xlucane Biosimilar Of Lucentis After Phase III Results
Hot on the heels of Samsung Bioepis receiving an EMA endorsement for its Byooviz version, Xbrane Biopharma has laid out plans for its own ranibizumab biosimilar, Xlucane, to be filed in both the EU and the US following positive Phase III results.
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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.
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.
Samsung Bioepis’ indication that it will not launch its FDA-approved ranibizumab biosimilar, Byooviz, before June 2022 has changed what we know about the competitive landscape for Lucentis in the US.