The two companies announce that the European Commission has granted a marketing authorization for Ximluci (ranibizumab), a biosimilar candidate referencing Lucentis.
This follows the positive opinion issued by the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) in September 2022. The centralized marketing authorization for Ximluci 10 mg/ml solution for injection is held by STADA and is valid in all 27 European Union member states, as well as in Iceland, Norway and Liechtenstein. The partners are preparing for launches in selected European markets early in 2023.
STADA and Xbrane agreement
In July 2018, STADA and Xbrane entered into an agreement under which the two companies are jointly responsible for development and for 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.
The partnership combines Xbrane’s patented protein-expression system and Europe-based production platform with STADA’s experienced clinical salesforce and key-account management teams, 125-year heritage, and extensive sales and marketing expertise throughout Europe as a top-four player in both generics and consumer healthcare.
Ximluci is an anti-VEGF (vascular endothelial growth factor) for the treatment of retinal vascular disorders, which are a leading cause of blindness globally. Ximluci 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.
Ranibizumab is the sixth biosimilar approved within STADA’s Specialty Care portfolio, joining adalimumab, bevacizumab, epoetin zeta, peg filgrastim and teriparatide.
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 the reference product Lucentis. The Phase 3 clinical study involved 580 patients with wet age-related macular degeneration. The primary endpoint of the study was the change in best corrected visual acuity (BCVA) at week 8 compared to the baseline. This was met, as the adjusted treatment differences between the two products were within the predefined equivalence margin.
Photo: Xbrane lab