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

European Medicines Agency

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 growth factor) for the treatment of retinal vascular disorders – a leading cause of blindness. Peter Goldschmidt, CEO of STADA, commented: “This positive opinion reflects STADA’s ongoing expansion of its biosimilars portfolio within Specialty Care, as well as STADA Specialty Care’s entry into a new therapeutic category – ophthalmology.”

If approved, ranibizumab will be the sixth product approved within STADA´s biosimilar portfolio, joining adalimumab, bevacizumab, epoetin zeta, pegfilgrastim and teriparatide. Further, XIMLUCI® will be the first biosimilar candidate authorized through the partnership between Xbrane and STADA, and the first biosimilar Xbrane has taken all the way from cell-line development to approval.