Tagged as: XIMLUCI

European Biosimilar Regulatory Updates

STADA and Xbrane Announce Approval of Ranibizumab Biosimilar in UK On January 16, 2023, STADA Arzneimittel AG (STADA) and Xbrane Biopharyma AB (Xbrane) announced that the UK’s Medicines and Healthcare product Regulatory Agency (MHRA) has granted marketing authorization for XIMLUCI (ranibizumab), a biosimilar of LUCENTIS.  XIMLUCI is an anti-VEGF (vascular…

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EMA Adopts Positive Opinion for STADA and Xbrane’s Ranibuzumab Biosimilar Candidate XIMLUCI®

On Sep 16, 2022, Partners STADA Arzneimittel AG (“STADA”) and Xbrane Biopharma AB (publ) (“Xbrane”) announced that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for XIMLUCI®.  XIMLUCI® is a biosimilar candidate referencing LUCENTIS® (ranibizumab), which is an anti-VEGF (vascular endothelial…

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