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.