Blog Big Molecule Watch November 13, 2022

STADA and Xbrane Announce Approval of Ranibizumab Biosimilar in Europe

On November 11, 2022, STADA Arzneimittel AG (“STADA”) and Xbrane Biopharma AB (“Xbrane”) announced that the European Commission has granted a marketing authorization for XIMLUCI (ranibizumab), a biosimilar to Genentech’s LUCENTIS. XIMLUCI is an anti-VEGF (vascular endothelial growth factor) for the treatment of retinal vascular disorders and has been approved in the European Union (EU) for the treatment of wet age-related macular degeneration (wet AMD), diabetic macular oedema (DME), diabetic retinopathy (PDR), retinal vein occlusion (RVO) and visual impairment due to choroidal neovascularization (CNV) in adults. The marketing authorization for XIMLUCI was based on a comprehensive comparative analytical assessment and a Phase 3 clinical study that demonstrated equivalent efficacy and comparable safety to LUCENTIS.

According to the press release, in July 2018, STADA and Xbrane entered into an agreement under which the two companies are jointly responsible for development and manufacturing the finished product. STADA holds the marketing authorizations and the commercial rights to the biosimilar across all territories included in the agreement, which covers Europe, the US, several countries in the Middle East and North Africa (MENA) region, and selected Asia-Pacific (APAC) markets.

Ranibizumab is the sixth biosimilar approved within STADA´s Specialty Care portfolio, joining adalimumab, bevacizumab, epoetin zeta, pegfilgrastim and teriparatide.

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