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 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.

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Yoko J. Bian
Goodwin Procter LLP
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