Ximluci® is a biosimilar candidate to ranibizumab, the original drug Lucentis®, a VEGFa inhibitor used to treat a number of serious eye diseases. Ximluci® addresses a market of around EUR 13 bn1) per year. The European Medicines Agency (EMA) approved Ximluci® in 2022, for the treatment of wet age-related macular degeneration (AMD), diabetic macular edema (DME), proliferative diabetic retinopathy (PDR),  retinal vein occlusion (RVO) and visual impairment due to choroidal neovascularization (CNV) in 27 member states in Europe. Eighteen months after launching, Ximluci® was available in 18 European markets and one market outside of Europe. In April, Xbrane received a CRL (Complete Response Letter) in response to our application for market approval for Ximluci® on the US market. The aim, and plan, remains to resubmit the BLA during Q4 2024. If successful, this would result in a BsUFA date in Q2 2025. This assumes a standardized review process of six months. Xbrane’s commercialization partner STADA is actively working to take Ximluci® to other regions such as the Middle East, Latin America and Southeast Asia. Applications for market approval have been submitted to various regulatory authorities in these regions. In May, STADA and Xbrane signed a collaboration agreement with Valorum Biologics, which will commercialize Ximluci® in the US. Ximluci® is approved in Europe in a vial containing the active substance, from which the ophthalmologist extracts the product into a syringe for injection into the eye. Xbrane also plans to launch a prefilled syringe for Ximluci® in Europe in 2025.

1) Evaluate Pharma; ”Originator Peak Sales Estimate 2026”.

Xdivane™ is a biosimilar candidate to nivolumab, original drug Opdivo®, a PD1 inhibitor for the treatment of various types of cancer. Opdivo® is expected to generate sales of EUR 13 bn1) and lose its patent protection during 2026–2031 depending on the country. Upscaling of Xdivane™ has successfully been implemented with contract manufacturers. The company sought acceptance from regulatory authorities for a reduced clinical development program and received feedback from both the EMA and the FDA on the basis of a demonstrated high analytical similarity against a comprehensive panel of analytical methods compared to the reference product. This affects the program’s timeline for out-licensing and increases the attraction in the business case as the reduced clinical development plan results in significant cost savings. The company is in active negotiations with Xdivane™ and hopeful to be able to conclude a deal before the end of November 2024.

2) “Novartis Full year 2023 product sales” and “Roche’s Full-Year Results 2023”

Xdarzane™ is a biosimilar candidate to daratumumab, original drug Darzalex®, an antibody that binds to CD38 for the treatment of multiple myeloma (around EUR 9 bn1) in estimated sales). The patent protection for Darzalex® is expected to expire in 2029–2031 depending on the country. Xdarzane™ is at the preclinical development stage with a focus on developing a cost-effective production process and demonstrating a biochemical similarity to the original drug.

2) “Novartis Full year 2023 product sales” and “Roche’s Full-Year Results 2023”